FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Indian Drugmaker Nailed for Falsifying Data

May 30, 2019
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A Gujarat, India finished drug manufacturer drew a warning letter from the FDA after an inspection turned up serious violations at its facility, including shredded and falsified data.

The agency’s Oct. 22-26, 2018 inspection of Centurion Laboratories’ site revealed torn up stability study data, analytical testing sheets, release forms and analysis calculations found in trash bags. Test results were recorded as within specification despite the out-of-specification results found in the trash. The company prepared and pre-signed blank stability study forms before recording the test data.

The FDA investigators also found issues with cleaning at the facility that created risks of cross-contamination and inconsistent drug products. In one room, a piece of equipment was marked as “cleaned,” but the equipment had visible product buildup inside and its air filter was damaged with multiple holes. The company explained that it was short on staff members because of a nine-day dancing festival.

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