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  5. Foshan Biours Biosciences Co., Ltd. - 611319 - 03/10/2021
  1. Warning Letters

WARNING LETTER

Foshan Biours Biosciences Co., Ltd. MARCS-CMS 611319 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Paul Huang
Recipient Title
General Manager/CEO
Foshan Biours Biosciences Co., Ltd.

13 East Xile Road, Tower B F1 Complex Bldg.
Rooms 201, 202, 203 (2nd Floor) & 302 (3rd Floor)
Foshan Shi
Guangdong Sheng, 528137
China

Issuing Office:
Center for Drug Evaluation and Research

United States

Warning Letter 320-21-34

March 10, 2021

Dear Mr. Huang:

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 3, 2020 request, and subsequent requests, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Foshan Biours Biosciences Co., Ltd., FEI 3011474550, at 13 East Xile Road, Tower B F1 Complex Bldg., Rooms 201, 202, 203 (2nd Floor) & 302 (3rd Floor), Foshan, Guangdong.

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)).

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Your firm manufactures an over-the-counter (OTC) drug product, (b)(4) Patch containing (b)(4). Your response to our request for records and other information under section 704(a)(4) indicates that you distributed this drug product into the United States without adequate finished drug product testing.

For example, in response to our request to provide release specifications of U.S. products and the test method used to evaluate them, you submitted a certificate of analysis for your OTC (b)(4) Patch that shows you did not conduct adequate testing for identity and strength of the active ingredient, (b)(4), as is required prior to release per 211.165(a). No other information provided was responsive to our request for information about release testing. Your response indicates that you do not perform assay testing for identity and strength of your active ingredient.

Without adequate testing, you do not have scientific evidence that your drug product batches conform to appropriate specifications prior to release.

In response to this letter, provide the following for all drug products imported to the United States:

• A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.
   o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the U.S. that are within expiry as of the date of this letter.
   o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

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

Based on the information you provided in response to our request for cleaning procedures for cleaning equipment for U.S. product lines, you have not conducted cleaning validation studies. For example, in response to our records request you indicated that there was no validated cleaning procedure for the equipment used in the manufacture and packaging of your OTC (b)(4) Patch. Additionally, you stated that the equipment used in the manufacture and packaging of your OTC (b)(4) Patch is not dedicated to that drug product.

Without cleaning validation studies you cannot demonstrate that your cleaning procedures for non-dedicated production equipment are adequate to prevent cross-contamination.

In response to this letter, provide the following for all drug products imported to the United States:

• Steps your firm has taken to develop an adequate cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
  o drugs with higher toxicities
  o drugs with higher drug potencies
  o drugs of lower solubility in their cleaning solvents
  o drugs with characteristics that make them difficult to clean
  o swabbing locations for areas that are most difficult to clean
  o maximum hold times before cleaning

In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.

• A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.

3. 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)).

In response to our request for a list all batches in stability and a list of all stability studies, you did not provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period. For example, your stability data for OTC (b)(4) Patch does not include testing for the active ingredient. Therefore, the data does not demonstrate that the drug’s active ingredient is stable throughout its shelf life.

In response to this letter, provide the following for all drug products imported to the United States:

• A comprehensive, independent assessment and corrective and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
  o Stability indicating methods, including both analytical and microbiological test methods
  o Stability studies for each drug product in its marketed 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 detailed definition of the specific attributes to be tested at each station (timepoint)

• All procedures that describe these and other elements of your remediated stability program,

CGMP Consultant Recommended

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. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. 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.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug product. You are responsible for investigating and determining the causes of any these violations and for preventing their recurrence or the occurrence of other violations.

Note that FDA placed the drug product manufactured by your firm on Import Alert 66-40 on October 22, 2020, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices within the meaning of section 501(a)(2)(B) of the FD&C Act. Drugs and drug products that appear to be adulterated or misbranded may be detained or refused admission without physical examination pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

All drugs and drug products manufactured by your firm may remain listed on this import alert until there is evidence establishing that the conditions that gave rise to the appearance of this violation have been resolved, and the Agency has confidence that future entries will be in compliance with the FD&C Act. This may include an inspection prior to the Agency considering the appearance of adulteration to be addressed.

Until all violations are addressed completely and we confirm your compliance with CGMP, they may be cause for FDA to withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to address any deviations and violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. 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 CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3011474550 and ATTN: CDR Frank Verni.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

CC (via email & UPS):
David Lennarz, U.S. Agent
144 Research Drive
Hampton, Virginia 23666
drugs@registrarcorp.com

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