佛山晋雄科技警告信

beiwei5du

Foshan Jinxiong Technology Co., Ltd. 6/26/18

	10903 New Hampshire Avenue Silver Spring, MD 20993

Via UPS                                                                                 Warning Letter 320-18-60
Return Receipt Requested

June 26, 2018

Mr. Eric Qiu
General Manager
Foshan Jinxiong Technology Co., Ltd.
Lijia Development Zone, Shang An Community
Danzao Town, Nanhai District
Foshan City, Guangdong Province 528223
China

Dear Mr. Qiu:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Jinxiong Technology Co., Ltd. at Foshan City, Guangdong Province from August 15–18, 2017.

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 product is 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).

We reviewed your September 3, 2017, response in detail.

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

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 identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Your firm is a contract manufacturer of over-the-counter (OTC) drug products marketed to children. You released multiple lots of OTC drug product without data to support their conformance to specifications, including identity and strength.

In your response, you acknowledged that the testing you perform on finished drug product does not include identity and strength of the active ingredient, and that your clients may do this testing after you release the drug product lots. You also stated that you will arrange to have your finished drug product tested for identity and strength by an external laboratory once a year.

Your response was inadequate because, although you updated the finished product specifications to include identity and strength of (b)(4), you did not include a testing requirement of each lot prior to distribution, for identity and strength as a condition of lot release. You also did not provide active ingredient identity and strength test results of retain samples to support the quality of the drugs you have distributed to the US.

In response to this letter, provide the following:

• all chemical and microbial test methods and specifications used to analyze each lot of your OTC drug products prior to a lot disposition decision; and
• a summary of test results obtained from testing retain samples of all OTC drug products within expiry that have been distributed in the United States. These test results should include identity and strength of active ingredients, and all other appropriate chemical and microbial quality attributes.
  
  

2.      Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to establish the reliability of component supplier analyses on which you rely in lieu of certain tests through appropriate validation of supplier’s test results at appropriate intervals (21 CFR 211.84(d)(1) and (2)).

Your firm failed to adequately test incoming components, including (b)(4), for their identity. Instead, your firm relied on certificates of analysis (COA) from unqualified suppliers.

In your response, you acknowledged that you do not perform identity testing on your incoming components, including your active ingredient, (b)(4). You also stated that you will seek out a laboratory that can perform identity testing on each batch of your active ingredient.

Your response was inadequate because you failed to indicate testing plans for other components of the drug product and your timeline for initiating identity testing on all incoming component lots. Your response also failed to indicate how you intend to establish the reliability of your suppliers if you plan to use their COA to assess the adequacy of components.

In response to this letter, provide the following:

• quality control release specifications for all incoming components, and the tests you perform for each lot;
• a summary of test results obtained from full testing of all your incoming components to validate the COA from each raw material manufacturer;
• a summary of your procedures for qualifying and overseeing the adequacy of contract facilities that test the OTC drug products you manufacture; and
• a comprehensive, independent review of your material system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified, assigned appropriate expiration or retest dates, and incoming material lot controls are adequate to prevent use of unsuitable containers, closures, and components.
  
  

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 such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

You did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products remain acceptable throughout their labeled expiry period. You established a (b)(4) shelf life based on the stability data of (b)(4) batch stored for up to 12 months. You also did not analyze this lot for active ingredient content.

In your response, you stated that you will test the stability samples of finished drug product up to 36 months, according to the requirements of your stability procedure. However, your response was inadequate because your procedure does not include chemical tests, including active ingredient content.

In response to this letter, provide the following:

• a revised ongoing stability SOP, including but not limited to adding a test for active ingredient content at each stability station; and
• stability test results of all drug products distributed in the United States within expiry using stability-indicating methods to determine if results meet specifications. If you obtain out-of-specification results, indicate the corrective actions you will take.
  
  

4.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

You lacked complete information related to the production and control of each lot. For example, you failed to have specific identification for each  lot of component, and production equipment, used in manufacturing. You also failed to have unique lot or control numbers for the distributed drug product. You provided our investigator with a list of more than (b)(4) batches manufactured in 2017 that lacked this basic information.

In your response, you described your new lot numbering system and how you revised your production records. You also provided a copy of the revised production record.

Responsibilities as a Contractor
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements, at https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf.

Quality Systems Guidance
See FDA’s guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing modern quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR, parts 210 and 211), at https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf.

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. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

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.

FDA placed your firm on Import Alert on February 14, 2018.

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 continuing to refuse admission of articles manufactured at Foshan Jinxiong Technology Co., Ltd. at Lijia Development Zone, Shang An Community, Danzao Town, Nanhai District, Foshan City, Guangdong Province 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 maybe subject to refusal 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 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 CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:

Cesar E. Matto
Senior Policy Advisor
U.S. Food and Drug Administration
White Oak Building 51, Room 4235
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA

Please identify your response with FEI 3011821481.
                                                                       
Sincerely,
/S/                                                                       
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

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佛山晋雄科技有限公司
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罗伊鲱

做玩具和化妆品的也开始做OTC药了