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Talk to a SpecialistTalk to a SpecialistCentaur Pharmaceuticals Private Ltd. received a warning letter for significant deviations from current good manufacturing practices (CGMP) in the production of active pharmaceutical ingredients (APIs), rendering their products adulterated. FDA inspectors found that the company's quality unit failed to maintain adequate document control over critical records, including analytical worksheets, incident reports, and non-conformance reports that were stored with unrestricted access in laboratory drawers and cabinets. The inspection also identified problems with duplicate document control numbers and inadequate procedures for destroying original CGMP documents without proper review and documentation. These failures demonstrated the company's inability to ensure their manufactured APIs complied with CGMP requirements.