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Monday, August 28, 2017

FDA Warning Letter | Bicooya Cosmetics Limited | GMP Violations











The U.S. Food and Drug Administration (FDA) has inspected drug manufacturing facility, Bicooya Cosmetics Limited at No. 17, Yan Hu Road, Shangxi Town, Zhejiang, from May 22–25, 2017.

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


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

1.    Your firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).

Investigator observed rodent feces throughout your facility:
·         in direct proximity to the filling machine where you manufacture OTC drug products
·         in direct proximity to the (b)(4) system, which produces (b)(4) incorporated in your drug products
·         throughout the warehouse, around both raw materials and finished drug products
Your over-the-counter (OTC) drug products include (b)(4) ointments and (b)(4).

2.    Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

For example, our investigator observed residue build-up in the (b)(4) tanks you use to manufacture OTC drug products, and damaged transfer hoses held together with plastic wrap. When an employee attempted to open a (b)(4) tank lid during the inspection, a hinge broke.

3.    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 did not test all lots of your drug products for active ingredient content prior to release. You also failed to conduct microbial testing (i.e., total count, objectionable microorganisms) for each batch of drug product you release.Your firm stated that your customer only requires microbiological tests to be performed (b)(4). Because you lack microbiological testing, there is insufficient assurance that the products you distribute are safe and sanitary.

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).  

Investigator requested batch records for OTC drug product lots distributed to the United States, including (b)(4) Ointment and (b)(4). You were unable to provide batch records.

In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for (b)(4) Ointment lot (b)(4), although this lot had already been distributed to the U.S. market.

CGMP consultant recommended

Based upon the nature of the violations FDA has been identified at firm that and strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34, to assist the firm in meeting CGMP requirements. Use of consultants does not relieve your firm’s obligation to comply with CGMP. However firm executive management is remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

Data Integrity Remediation

Firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.

Source: FDA


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