Drugs

CGMP Violations at Foshan Jinxiong Technology

An 8/15-8/18/17 FDA inspection at Foshan Jinxiong Technology, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/26 Warning Letter. Specific violations noted in the letter, were:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including 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 establish the reliability of component supplier analyses on which the company relied in lieu of certain tests through appropriate validation of suppliers’ test results at appropriate intervals;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates; 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 letter states FDA’s position that the company is responsible for the quality of the drugs it produces as a contract facility, regardless of arrangements in place with product owners. “Based upon the nature of the violations we identified at your firm,” the letter says. “we strongly recommend engaging a consultant qualified … to assist your firm in meeting CGMP requirements.” The company was placed on an import alert 2/14.

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

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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