FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data

The FDA has issued a new Warning Letter dated 03 March 2026, flagging systemic data integrity and quality failures at an Indian contract testing laboratory.

Data Integrity

At the center of the findings is a fundamental breakdown in data governance. The Warning Letter states that the "investigator discovered two garbage bags containing torn analytical records, including chromatographic results, unidentified number lists, and impurity method validation spreadsheets with handwritten notes. For the method validation study, official records contained only handwritten values, while the original data was discarded in the garbage bags. [...] Additionally, laboratory staff used unofficial personal diaries to record procedures, analytical observations, results, method modifications, and deviation descriptions."

The company argued that the validation documents in the garbage bags were not related to drug products destined for the United States. However, the FDA makes clear that such practices eliminate traceability and raise serious doubts about the reliability of all data generated at the site, independent of the intended market.

Laboratory Deviations and Unexplained Out-of-Specification (OOS) Results

The FDA found that an unofficial audit form was used to document laboratory deficiencies, "including a discrepancy in which microbiological sample plates could not be located in an incubator despite a logbook entry indicating the plates had been placed there."

Further deficiencies were identified in OOS and deviation handling. The firm reissued passing test results without any documented investigation after initial out-of-specification findings, and deviations were handled outside the formal quality system without CAPA tracking.

The company’s argument that certain tests were conducted “for informational purposes only” was explicitly rejected by the FDA, which reiterated that all testing activities must comply with CGMP requirements.

Documentation Practices

In addition, the FDA observed non-contemporaneous and manipulated documentation practices, including pre-signed maintenance records and backdated analytical data. Notably, these issues had been cited in previous inspections, reinforcing FDA’s view that the deficiencies are systemic rather than isolated.

The situation is further aggravated by inspection obstruction. The FDA writes: "Your firm limited access to records requested during the inspection. At the initiation of the inspection, our investigator observed your firm attempting to remove two large garbage bags later determined to contain analytical documents. Other documents that had been removed from the quality control laboratory were requested but were not provided to our investigator."

To see the complete list of observations, please refer to the full Warning Letter to Tentamus India Private Limited published on the FDA’s website.