U.S. Food and Drug Administration

Dear Mr. Mehta:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Anicare Pharmaceutical Pvt. Ltd., at Plot No. A 143/5&6, TTC Industrial Area, Khairne Village, Thane-Belapur Rd., Navi Mumbai, from July 30 to August 3, 2018.

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This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

As formulated and labeled, Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream are unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Anicare Pharmaceuticals Pvt Ltd. also manufactures the over-the-counter (OTC) drug products Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, Budpak Feminine Anti-Itch Cream, Budpak First Aid Cream, Budpak Hemorrhoid Anesthetic Ointment, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Budpak Triple Antibiotic First Aid Antibiotic Ointment, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Antifungal Athlete’s Foot Cream, Lucky SuperSoft First Aid Triple Antibiotic, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-Itch Cream, U First Aid Cream, U Hemorrhoid Anesthetic Ointment, and U Muscle Rub Pain Reliever Gel that are misbranded under sections 502(c) and (x) of the FD&C Act, 21 U.S.C. 352(c) and (x). Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

We reviewed your August 17, 2018, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Your stability program is inadequate because you failed to test your drug products, such as (b)(4), for microbial attributes (e.g., total count and absence of objectionable microorganisms). Additionally, you did not use stability indicating assay methods to determine active ingredient levels.

In your response, you indicated that your revised procedure for stability studies includes testing samples for microbial growth. Your response is inadequate because it does not include your revised stability program protocol and microbial testing results from stability studies. Your response also lacks a plan to perform microbiological examination testing of retain samples for all batches that remain within expiry.

In response to this letter, provide:

• A comprehensive, independent assessment and corrective action and preventative action (CAPA) plan to ensure the adequacy of your stability program. Your CAPA plan should include, but not be limited to:

o A remedied standard operating procedure (SOP) describing your stability program

o Stability indicating methods

o Stability studies for each drug product in its container-closure system before distribution is permitted

o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid

o Specific attributes to be tested at each station

• A retrospective risk assessment of the stability of drug products on the U.S. market within expiry. Include your CAPA plan, including testing your retain samples for both chemical and microbiological attributes, to ensure that these drug products will maintain their purported quality attributes throughout their expiry.

2. Your firm’s quality control unit did not review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess (21 CFR 211.100(a)).

A.) You failed to adequately validate your drug product manufacturing processes. For example, you lacked the following validation studies:

• An adequate demonstration of homogeneity throughout a batch (e.g. lack of (b)(4) tank samples at specific locations)
• Adequate validation of your (b)(4) filling operations

The purpose of process validation is to establish scientific evidence that a process is capable of consistently delivering quality product. Sampling and testing of in-process materials and drug products requires control procedures to monitor output and validate performance of manufacturing processes that may cause variability in drug product characteristics. Samples must be representative of the batch, provide appropriate statistical confidence, and meet predetermined specifications. See FDA’s guidance document Process Validation: General Principles and Practices for approaches that FDA considers appropriate elements of process validation at http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070336.pdf.

In your response, you indicated you developed a new procedure for homogeneity and uniformity testing. Your response was inadequate because it did not include a comprehensive review of your process validation studies for all of your drug products.

In response to this letter, provide:

• A comprehensive review of your manufacturing processes to determine your current state of control and to identify any deficiencies in your validation studies. Include your CAPA plan or plans.
• A data-driven and scientifically sound validation program that identifies and controls all sources of variability such that your production and packaging processes will consistently meet appropriate manufacturing standards and parameters. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, and determining the capability and reliability of each manufacturing process step and control.
• A retrospective risk assessment of drug products on the U.S. market within expiry affected by inadequate process validation studies.

B.) You lacked adequate design and control over your (b)(4) system. Our investigator observed that your (b)(4) system was not in constant circulation. Raw data related to chemical testing of the (b)(4) was unavailable during the inspection. Additionally, the sampling plan for your (b)(4) system was inadequate. It is essential that (b)(4) used in the manufacturing and equipment cleaning meet chemical standards for (b)(4), USP, and appropriate microbial standards for your topical products.

In your response, you indicated that your SOP was revised to include sampling frequency. Your response is inadequate because it did not provide your revised procedure or evidence to support the sampling points of use, frequency, and results.

In response to this letter, provide:

• A comprehensive, independent assessment of your (b)(4) system design, control, and maintenance.
• A comprehensive CAPA plan for remediating design, control, and maintenance of the (b)(4) system.
• Appropriate microbial action and alert limits to ensure this system produces (b)(4) suitable for the intended uses of each of your products.
• Your (b)(4) system validation report. Include the summary of improvements made to system design and those made for ongoing control and maintenance.
• A detailed risk assessment addressing the potential effects of the (b)(4) system deficiencies on the quality of all drug product batches in U.S. distribution within expiry. If deficiencies are found, specify actions that you will take, such as customer notifications and product recalls.

3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Your cleaning validation program for manufacturing equipment is inadequate.

For example, your report APPL/CVPD/010, dated January 29, 2014, documented the cleaning validation of (b)(4) from (b)(4) tank APPL/PROD/02. The report concluded that (b)(4) washings with water achieved a (b)(4) sample acceptance criteria of less than (b)(4) ppm for the (b)(4) tank. However, your report documented values that indicated presence of chemicals greater than your acceptance criteria of (b)(4) ppm.

Additionally, on February 2, 2018, after production of (b)(4), your water sample collected from the (b)(4) tank failed your chemical determination cleaning acceptance criteria. During the inspection, you indicated this failure was not investigated. Because this tank was used to manufacture different drug products, there was a risk of cross-contamination.

In your response, you indicated that a new system and process for cleaning the vessels will be validated. Your response is inadequate because it did not include an assessment of other equipment cleaning validations and lacked a timeframe for completion.

In response to this letter, provide:

• A comprehensive plan to evaluate cleaning procedures, practices, and validation study results for each piece of manufacturing equipment used to manufacture more than one product
• Scientific rationale for your cleaning validation strategy to ensure your cleaning procedures are effective
• A summary of updates to your cleaning validation protocol incorporating conditions identified as worst case. This should include, but not be limited to:

o Evaluating drugs of the highest toxicity

o Assessing drugs of the lowest solubility in their cleaning solvents

o Evaluating drugs with characteristics that make them difficult to clean

o Swabbing equipment locations that are most difficult to clean

• A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for new products, processes, and equipment
• A retrospective risk assessment of drug products in the U.S. market within expiry affected by your inadequate cleaning program

Quality Unit Authority

Significant findings in this letter indicate that your quality unit is not fully exercising its authority and/or responsibilities. Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.

CGMP Consultant Recommended

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Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Unapproved New Drug Charges

Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream

Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because they are intended to affect the structure or any function of the body. Specifically, these products are intended as external analgesics.

Examples of claims observed on your products’ labels that establish the intended uses of the products as defined in 21 CFR 201.128 include, but may not be limited to, the following:

“Uses…temporarily relieves itching associated with minor skin irritations…due to: eczema…psoriasis…poison ivy…”

“Anti-Itch”

Drug products intended for external analgesic indications such as the relief of itching are being evaluated under the Tentative Final Monograph (TFM) for External Analgesic Drug Products for Over-the-Counter Human Use (48 FR 5852, February 8, 1983). Pending the promulgation of a final rule, the agency generally does not intend to object to the marketing of products that meet both the proposed formulation and labeling conditions outlined in the TFM and each general condition in 21 CFR 330.1 unless a product poses a public health concern. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of the FD&C Act (section 505).

However, the formulation and labeling for Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream are not consistent with the conditions proposed for external analgesic drug products, see the TFM for External Analgesic Drug Products for Over-the-Counter Human Use (48 FR 5852, February 8, 1983). Specifically, the Lucky SuperSoft Hydrocortisone Anti-Itch Cream label presents aloe as a “healing” ingredient. According to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans. Although your firm does not specifically list aloe as an active ingredient, your label claim demonstrates that aloe is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity. Aloe is not a proposed active ingredient in the External Analgesic TFM (see 48 FR 5852, February 8, 1983).

Regarding U Hydrocortisone 1% Anti-Itch Cream the product labeling includes indications such as, “Helps Heal Rashes” that are not proposed under this rulemaking.

Furthermore, we are not aware of any adequate and well controlled clinical trials in the published literature that support a determination that Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Creamare generally recognized as safe and effective for its labeled indications. Additionally, we are not aware of similar OTC products as formulated and labeled that were available in the United States market on or before the inception of the OTC Drug Review.

Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream, as labeled, are therefore new drugs within the meaning of section 201(p) of the FD&C Act because they are not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. “New drugs” may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream are not the subject of an approved new drug application; therefore, marketing these products in the United States is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d) and violates section 505 of the FD&C Act.

Misbranding Charges

Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, Budpak Feminine Anti-Itch Cream, Budpak First Aid Cream, Budpak Hemorrhoid Anesthetic Ointment, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Budpak Triple Antibiotic First Aid Antibiotic Ointment, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Antifungal Athlete’s Foot Cream, Lucky SuperSoft First Aid Triple Antibiotic, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-Itch Cream, U First Aid Cream, U Hemorrhoid Anesthetic Ointment, U Muscle Rub Pain Reliever Gel

Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Feminine Anti-Itch Cream, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-Itch Cream, U Muscle Rub Pain Reliever Gel, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, and Lucky SuperSoft Antifungal Athlete’s Foot Cream, Budpak Hemorrhoid Anesthetic Ointment, U Hemorrhoid Anesthetic Ointment, Budpak Triple Antibiotic First Aid Antibiotic Ointment, Lucky SuperSoft First Aid Triple Antibiotic, Budpak First Aid Cream, and U First Aid Cream are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because they are intended to affect the structure or any function of the body.

Specifically, Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Feminine Anti-Itch Cream, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-Itch Cream, and U Muscle Rub Pain Reliever Gel are intended for use as external analgesics. Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, and Lucky SuperSoft Antifungal Athlete’s Foot Cream are intended for use as topical antifungals. Budpak Hemorrhoid Anesthetic Ointment and U Hemorrhoid Anesthetic Ointment are intended for use as anorectal drug products. Budpak Triple Antibiotic First Aid Antibiotic Ointment and Lucky SuperSoft First Aid Triple Antibiotic are intended for use as first aid antibiotics. Budpak First Aid Cream and U First Aid Cream are intended for use as first aid antiseptics.

Below are examples of statements observed on your products’ labels that establish the intended uses of the products as defined in 21 CFR 201.128 include, but may not be limited to, the “Drug Facts” panel on the labels of these products.

Budpak 1% Hydrocortisone Anti-Itch Cream

“Uses for the temporary relief of itching associated with minor skin irritations and rashes due to: eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, oak sumac, soaps, detergents, cosmetics, jewelry, external genital, feminine and anal itching.”

Budpak Feminine Anti-Itch Cream

“Uses temporarily relieves itching”

Budpak Medicated Anti-Itch

“Uses for the temporary relief of pain and itching associated with minor skin irritation, allergic itches, rashes, hives, minor burns, insect bites, poison ivy, poison oak, poison sumac”

Budpak Muscle Rub Pain Relieving Gel

“Uses provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.”

Lucky SuperSoft Itch Stopping Cream

“Uses temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy poison oak, and poison sumac”

Lucky SuperSoft Muscle & Joint Pain Relieving Cream

“Uses temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains”

U Anti-Itch Cream

“Uses for the temporary relief of pain and itching associated with: minor skin irritation, allergic itches, rashes, hives, minor burns, insect bites, poison ivy, poison oak, poison sumac”

U Muscle Rub Pain Reliever Gel

“Uses provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.”

Budpak Antifungal 1% Clotrimazole Cream

“Uses cures most athlete’s foot, jock itch, and ringworm”

Budpak Antifungal Miconazole Nitrate Cream

“Uses cures most athlete’s foot, jock itch, and ringworm”

Lucky SuperSoft Antifungal Athlete’s Foot Cream

“Uses cures most athlete’s foot, jock itch, and ringworm”

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Budpak Hemorrhoid Anesthetic Ointment

“Uses for the temporary relief of local anorectal burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.”

U Hemorrhoid Anesthetic Ointment

“Uses for the temporary relief of local anorectal burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.”

Budpak Triple Antibiotic First Aid Antibiotic Ointment

“Uses first aid to help prevent infection in minor cuts, scrapes, burns”

Lucky SuperSoft First Aid Triple Antibiotic

“Uses first aid to help prevent infection in minor: cuts, scrapes, burns”

Budpak First Aid Cream

“Uses first aid to help prevent risk of skin infection in minor cuts, scrapes, or burns.”

U First Aid Cream

“Uses first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.”

The labeling for such drugs, like all OTC drugs, must comply with all the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21, 21 CFR. However, your products do not meet these requirements for the reasons described below.

Budpak Muscle Rub Pain Relieving Gel and U Muscle Rub Pain Reliever Gel are misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c) because their labels fail to bear a complete statement of identity as required under 21 CFR 201.61. In the case of a drug that has an established name, the statement of identity must contain the established name and the general pharmacological action(s) or principal intended action(s) of the drug in the principal display panel. The labels for these products fail to include the established name of the drug as part of the statement of identity. Specifically, the labels fail to include menthol on the product’s principal display panel.

Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, Budpak Feminine Anti-Itch Cream, Budpak First Aid Cream, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, and Budpak Triple Antibiotic First Aid Antibiotic Ointment contain labeling information both in English and Spanish. Dual language labeling with English and another language is permissible when labeled in accordance to 21 CFR 201.15 and not otherwise false or misleading. Please note, 21 CFR 201.15 states that “all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language” . . . and “if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.” The labeling for these products are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c) because they are not labeled in accordance to 21 CFR 201.15. Specifically, the labels for these products are not labeled in accordance to 21 CFR 201.15 because their labels do not include a “Drug Facts” panel in the Spanish language.

Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, Budpak Feminine Anti-Itch Cream, Budpak First Aid Cream, Budpak Hemorrhoid Anesthetic Ointment, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Budpak Triple Antibiotic First Aid Antibiotic Ointment, Lucky SuperSoft Antifungal Athlete’s Foot Cream, Lucky SuperSoft First Aid Triple Antibiotic, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-itch Cream, U First Aid Cream, U Hemorrhoid Anesthetic Ointment, and U Muscle Rub Pain Reliever Gel are misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x) because the products’ labels fail to disclose a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug. Please note that section 201(k) of the FD&C Act defines the term “label” as “…a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under the authority of the FD&C Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such…also appears on the outside container….” Therefore, the domestic address or domestic telephone number must appear on the immediate container label and on the outside container label if one exists.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Therefore, the marketing of Budpak 1% Hydrocortisone Anti-Itch Cream, Budpak Antifungal 1% Clotrimazole Cream, Budpak Antifungal Miconazole Nitrate Cream, Budpak Feminine Anti-Itch Cream, Budpak First Aid Cream, Budpak Hemorrhoid Anesthetic Ointment, Budpak Medicated Anti-Itch, Budpak Muscle Rub Pain Relieving Gel, Budpak Triple Antibiotic First Aid Antibiotic Ointment, Lucky SuperSoft Itch Stopping Cream, Lucky SuperSoft Antifungal Athlete’s Foot Cream, Lucky SuperSoft First Aid Triple Antibiotic, Lucky SuperSoft Muscle & Joint Pain Relieving Cream, U Anti-Itch Cream, U First Aid Cream, U Hemorrhoid Anesthetic Ointment, and U Muscle Rub Pain Reliever Gel violates this provision of the FD&C Act.

Conclusion

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at [email protected], so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Anicare Pharmaceutical Pvt. Ltd., at Plot No. A 143/5&6, TTC Industrial Area, Khairne Village, Thane-Belapur Rd., Navi Mumbai into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to [email protected] or mail your reply to:

Joseph Lambert, Pharm.D.

Compliance Officer

U.S. Food and Drug Administration

White Oak Building 51, Room 4359

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your response with FEI 3007450508.

Sincerely,

/S/

Francis Godwin

Acting Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

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