FDA Warning Letter Flags Serious Data Integrity Failures at Indian Lab

The U.S. Food and Drug Administration has issued a Warning Letter dated March 3, 2026, highlighting major data integrity and quality lapses at an Indian contract testing laboratory, Tentamus India Private Limited.

At the core of the findings is a breakdown in data management. Inspectors reported discovering torn analytical records in garbage bags, including chromatographic results and validation data, while official records contained only handwritten summaries. Staff also maintained unofficial personal diaries to log procedures and results, raising concerns about traceability and reliability.

The agency further identified issues in handling out-of-specification (OOS) results, where failing outcomes were replaced with passing results without proper investigation. Deviations were not managed within formal quality systems, and corrective actions were not documented.

Additional concerns included backdated records, pre-signed documents, and restricted access to requested materials during inspection. The FDA noted that these recurring issues suggest systemic failures rather than isolated incidents.

30-03-2026