FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - August 22, 2025

An FDA inspection of Tentamus India Private Limited, a contract testing laboratory in Hyderabad, Telangana, India, conducted from August 14 to August 22, 2025, revealed significant data integrity and quality control deficiencies. The FDA issued a Form 483, citing multiple observations indicating potential violations of Good Manufacturing Practices.

Key issues included a systemic failure within the Quality Control unit, evidenced by the destruction of critical GMP documents, including chromatograms and raw data, and employees attempting to hide and backdate incomplete test documents. Investigators found torn GMP documents in trash bags and observed employees using personal diaries to record initial testing information, leading to adjustments of metadata to meet passing limits. There was also a lack of adequate oversight on the issuance and reconciliation of GMP forms and analytical worksheets.

Furthermore, the firm failed to adequately investigate unexplained discrepancies, often correcting issues informally without root cause analysis or corrective actions. Examples included reissuing test reports with "Too Numerous To Count" results without investigation and using an expired reference standard for over a year and a half in numerous analyses. A critical digital colony counter, essential for microbial plate colony counts, had non-operational lights for approximately seven years without repair, leading to potential inaccuracies.

Repeat observations from a September 2022 inspection highlight a persistent failure to follow established laboratory control mechanisms, including delayed and non-contemporaneous documentation, and backdating records. The company's leadership also provided misleading information regarding 'Routine Process Audit' reports. These findings necessitate comprehensive corrective and preventive actions to ensure data integrity, adherence to procedures, and reliable testing results.