Drugs

Hangzhou Badi CGMP Violations

A 3/19-3/21 FDA inspection at Hangzhou Badi Daily Use Chemical Company, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations. An 8/29 Warning Letter says specific violations were:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory compliance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to conduct at least one test to verify the identity of each component of a drug product;
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to assure that the drug product bore an expiration date that was supported by appropriate stability testing.

FDA says it cited similar CGMP violations following a 3/28-4/1/16 inspection. “You proposed specific remediation for these violations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The letter acknowledges the firm’s commitment to stop producing drugs for U.S. distribution. FDA recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements if it intends to resume manufacturing for the U.S. market. It also recommends that the consultant perform a comprehensive audit of Hangzhou’s entire operation for CGMP compliance and that the consultant evaluate the completion and efficacy of the company’s corrective and preventive actions before pursuing resolution of its compliance status with FDA.

The letter also discusses violations involving unapproved new drugs, misbranding, and cosmetics. The firm was placed on an import alert 7/30.

Hangzhou Badi was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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