Drugs

FDA Finds CGMP Violations at Zhejiang Ludao

An 8/14-8/18/17 FDA inspection at Zhejiang Ludao Technology Co., Taizhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/23 Warning Letter. Specific violations cited in the letter were:

failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
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 relies in lieu of certain tests through appropriate validation of suppliers’ test results at appropriate intervals; and
failing to follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

The agency recommends that the company engage a qualified consultant to assist in remediation of the quality system that does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures. It says the company should provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and (3) a management strategy for the firm including details of a global corrective and preventive action plan.

FDA also recommends the company engage a qualified consultant to assist it in meeting CGMP requirements. “In addition to assisting with data integrity remediation, we request that the qualified consultant comprehensively audit your facilities, methods, controls, and quality systems to ensure they are in compliance with CGMP requirements,” the letter says.

The firm was placed on an import alert 12/28/17.

Zhejiang Ludao 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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