Drugs

CGMP Issues Seen in Foshan Records Review

FDA says its review of records submitted by over-the-counter drug product manufacturer Foshan Yiying Hygiene Products Co., in Lishui Town, Guangdong, China, in response to an agency request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/10 Warning Letter says the specific violations were:

failure to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to assure that the drug product bears an expiration date that is supported by appropriate stability testing;
failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

FDA recommends that Foshan retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The letter says the consultant should perform a six-system audit of the firm’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective actions before it pursues resolution of its compliance status with FDA.

The agency placed all the firm’s products on an 8/27 Import Alert. Foshan Yiying was told to correct all 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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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome