Drugs

CGMP Violations at Shanwei Honghui Daily Appliance Co.

David McFarland

— 1 min read
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A 7/31-8/3/17 FDA inspection at Shanwei Honghui Daily Appliance Co., Ltd., Shanwei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5/17 Warning Letter. Specific violations cited in the letter were: 

  •          failing 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;
  •          failing to follow written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
  • ·         failing to perform, 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, and to conduct appropriate testing for each batch of drug product required to be free of objectionable microorganisms;
  • ·         failing to ensure the identity of components, including active ingredients and excipients from various suppliers; and
  • ·         failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The agency recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements. It was placed on an import alert 11/2/17.

FDA says the company’s response accepted the violations shown on an FDA-483 and blamed its lack of FDA experience. “Your response was inadequate and lacked detail,” the letter says. “While you provided various documents, you did not specifically address the deficiencies identified during the inspection. You also did not conduct a retrospective review of your products already distributed in the United States under the violative conditions detailed.”

Shanwei was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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