The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India.
The investigator found that the firm had no documentation of validation or verification of its analytical methods. In addition, the results of analytical data found in a product development folder differed greatly from the firm’s recorded test results.
The agency asked the company to improve and document its method validation and verification studies involved in product release and summarize impact assessment for released batches.
The FDA also called for an independent review of the facility’s laboratory practices, methods, equipment and analyst competencies, along with a corrective action and preventive action plan to “fully remediate” its laboratory.
The facility’s audit trail feature was found to be disabled on instruments involved in quality control testing of active pharmaceutical ingredients, including its high performance liquid chromatography system.