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WARNING LETTER

Jiangmen Nowadays Daily Goods Co., Ltd. MARCS-CMS 526243 —


Recipient:
Recipient Name
Mr. Li Jin Zhao
Jiangmen Nowadays Daily Goods Co., Ltd.

Boyukou Liangde Chong Industrial Zone, Sanjiang Town, Xinhui District

Jiangmen, Guangdong
529000
China

Issuing Office:
Center for Drug Evaluation and Research

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

Via UPS                                                                                 Warning Letter 320-17-50
Return Receipt Requested
 
September 12, 2017
           
 
Mr. Li Jin Zhao
Factory Director
Jiangmen Nowadays Daily Goods Co., Ltd.
Boyukou Liangde Chong Industrial Zone, Sanjiang Town, Xinhui District
Jiangmen, Guangdong, 529000
China
 
Dear Mr. Li Jin Zhao:
 
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jiangmen Nowadays Daily Goods Co., Ltd., at Boyukou Liangde Chong Industrial Zone, Sanjiang Town, Xinhui District, Jiangmen, Guangdong, from March 6 to 9, 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 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).
 
We reviewed your March 28, 2017, 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.
 
CGMP Violations
 
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)).
 
You released your over-the-counter (OTC) drug products, such as (b)(4) and (b)(4), without adequately testing them for conformance to specifications, including identity and strength.
 
2.    Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1),(2)).
 
You failed to test incoming active pharmaceutical ingredients and other components used to manufacture OTC drug products to determine their identity, purity, strength, and other appropriate quality attributes. Instead, your firm relied solely on certificates of analysis from unqualified suppliers.
 
3.      Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
 
You have not established that your (b)(4) system is adequately designed, controlled, maintained, and monitored to ensure it consistently produces (b)(4) that meets the (b)(4) USP monograph specifications and appropriate microbial limits. (b)(4) from this unvalidated system is used as a component in your OTC drug products.
 
(b)(4) must be suitable for its intended use, and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.
 
4.    Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
 
You have not validated the processes used to manufacture your OTC drug products. You did not perform process qualification studies, and also lack an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. See FDA’s guidance document, Process Validation: General Principles and Practices, for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.
 
Inadequate Response
 
You did not provide sufficient details or evidence that your firm will remediate your operations to ensure compliance with CGMP. In response to this letter, provide the following. 
  • The quality control test methods and specifications used to analyze each drug product batch prior to a batch release decision. Include both chemical and microbial quality attributes.
  • Timelines for testing all in-date drug products for identity and strength of active ingredients and all other appropriate quality attributes, including total count and objectionable microorganisms. Specify the actions that you will take, such as notifying customers and product recalls, if any batch is found to be of substandard quality.
  • Batch release specifications for all incoming components, and a description of the tests to be conducted for each batch.
  • A summary of test results obtained from full testing of each of your incoming components in order to validate vendors’ certificates of analysis. Also include a commitment to test each incoming component lot for identification.
  • Detailed plans for validating, maintaining, and monitoring your (b)(4) system.
  • Timelines for process performance qualification for each of your drug products, and a detailed summary of your approach for routinely monitoring intra-batch and inter-batch variations.
CGMP Consultant Recommended
 
Based upon the nature of the violations identified at your firm, you should undertake a comprehensive and global assessment to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements. We strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.
 
We request that the qualified consultant provide FDA with a detailed written report describing their efforts to assist with comprehensive remediation of your facilities, methods, controls, and quality systems to ensure they are in compliance with 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.
 
Formulation and Labeling Concerns
 
We have not conducted a complete formulation and labeling examination of all your products. We remind you that it is your responsibility to manufacture and/or distribute drug products that comply with all requirements of Federal law, and to ensure that your products are safe and effective and do not violate the provisions of the FD&C Act and its implementing regulations.
 
We note, however, you manufacture products—(b)(4), and (b)(4)—with labeling that causes them to be drugs subject to the FD&C Act.
 
For example, (b)(4) bears the claim “(b)(4).” These claims indicate that this product is intended for use as a “drug” as defined by section 201(g)(1)(B) of the FD&C Act 21 U.S.C. 321(g)(1)(B) because it is intended for use in 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 it is intended for use in the structure or any function of the body of man. Specifically, (b)(4), and any other similarly positioned products are intended for use as (b)(4).
 
OTC drug products intended as (b)(4) are being evaluated under ongoing rulemaking for OTC Topical (b)(4) Drug Products as part of FDA’s OTC Drug Review. See the (b)(4). Pending a final monograph/rule, FDA does not object to the marketing of products that meet both the formulation and labeling requirements described in the proposed rule.
 
Such marketing, however, is subject to the risk that a final rule may require reformulation, relabeling, or FDA approval through the “new drug” procedures of section 505 of the FD&C Act 21 U.S.C. 355. Please review the labeling and formulation of your drug products to ensure that they are formulated and labeled in accordance with the proposed rule above, or otherwise eligible for marketing in the United States under the FD&C Act.  
 
For your information, drug products intended as consumer (b)(4) are covered by the OTC Drug Review if they contain (b)(4). In addition, certain U.S. Department of Agriculture-authorized “(b)(4)” intended for use exclusively by (b)(4) are also covered under the OTC Drug Review. However, we note that a drug product containing (b)(4) intended for use as a topical (b)(4) would require approval of a new drug application (NDA) prior to marketing in the United States, because the ingredient is not covered by FDA’s OTC Drug Review and therefore, there is no applicable OTC monograph for such products.
 
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 66-40 on June 7, 2017.
 
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 Jiangmen Nowadays Daily Goods Co., Ltd., Boyukou Liangde Chong Industrial Zone, Sanjiang Town, Xinhui District, Jiangmen, Guangdong, 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 CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
            Metitia Gramby Sanders, Consumer Safety 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 3009490758.
 
 
Sincerely,
/S/ 
Thomas J. Cosgrove
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research