Drugs

Multiple Violations at Beijing Xinggu Lvsan

A 4/11-4/15 FDA inspection at Beijing Xinggu Lvsan Technology Co. (formerly Bejing Lvsan Technology Co.), Beijing, China, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in the firm’s manufacturing of finished drugs. A 10/5 Warning Letter says specific violations were:

failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of the component supplier’s analysis at appropriate intervals;
failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
failing to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms;
failing to establish 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
failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also says the 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 test.”

FDA says the firm’s alcohol and non-alcohol hand sanitizers are considered legally to be unapproved new drugs that are misbranded.

The agency recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market. It recommends the consultant perform a comprehensive audit of the firm’s total operation for CGMP compliance and evaluate the completion and efficacy of corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

Beijing Xinggu Lvsan was placed on an import alert 8/1.

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

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