Drugs

Zhejiang Huahai Pharmaceutical CGMP Issues

A 1/16-1/24 FDA inspection at Zhejiang Huahai Pharmaceutical Co., Ltd., in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/6 Warning Letter says the specific violations were:

failure 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;
failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas; and
failure to establish adequate written procedures and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says the firm’s responses to the inspection observations were inadequate. FDA recommends that Zhejiang engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Zhejiang was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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