Drugs

Hangzhou Linkeweier CGMP Violations

A 9/11-9/17/19 FDA inspection at Hangzhou Linkeweier Daily Chemicals Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing regulations (CGMP) for finished pharmaceuticals. A 3/13 Warning Letter says specific violations were:

failing to conduct for each batch of drug product appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms;
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of any component supplier’s test analyses at appropriate intervals;
failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failing 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.

FDA says the firm’s quality systems are inadequate and recommends that it retain a qualified consultant to conduct a comprehensive audit of the firm’s entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of the firm’s corrective and preventive actions before resolution of FDA compliance status is pursued.

The letter reminds the company that it is responsible for the quality of the drugs it produces as a contract manufacturing facility regardless of any agreements in place with its customers.

Hangzhou was placed on an import alert on 3/9. The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing all the actions.

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