Drugs

Hangzhou Karic Inspection Violations

A 3/26-3/29 FDA inspection at Hangzhou Karic Commodities Co., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/31 Warning Letter identified specific violations as:

failing to have, 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;
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 firm’s component supplier’s test analyses at appropriate intervals;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to establish adequate 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.

The letter reminds Hangzhou that it is responsible for the quality of drugs it produces as a contract facility, regardless of the agreements in place with product owners. The agency says the company’s response “provided limited corrective actions and did not provide sufficient detail and evidence to support that your proposed corrective actions will bring your operations and distributed drug products into compliance with CGMP.” It also reminds the company that despite its statement that it only manufactures cosmetics, FDA considers them to be drug products.

“We strongly recommend engaging a consultant to assist your firm in meeting the applicable CGMP requirements,” the letter says. “Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP.”

FDA placed the company on import alert 7/16. Hangzhou 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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