French Drugmaker Gets Warning Letter for Testing Deficiencies, Process Validation Issues

June 26, 2018

The FDA hit Biologique Recherche with a warning letter after observing multiple violations at its Paris facility, noting inadequate testing methods, quality control concerns and a lack of validation for manufacturing processes, among other issues.

The investigation revealed that the firm released an OTC drug product without properly testing its active ingredients and requested that the company provide all chemical and microbial test methods and specifications involved in analyzing OTC batches. The agency also requested a summary of test results for retain samples of relevant OTC drug products that were distributed in the U.S.

The French drug manufacturer also relied on certificates of analysis from unqualified suppliers instead of testing the attributes of incoming raw materials used in manufacturing. The company was asked to give quality control release specifications for all incoming components and the tests used for each lot. It was also requested to provide summaries of test results and procedures used to qualify COAs and contract facilities, as well as a comprehensive, independent review of its material system to ensure all ingredients and items received from suppliers are qualified.

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