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# FDA Cites Data Integrity, Quality Control at Aurobindo Facility
- URL: https://www.fdaweb.com/fda-cites-data-integrity-quality-control-at-aurobindo-facility/
- Published: 2026-02-20T12:00:00.000Z
- Updated: 2026-09-14T13:34:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160697

FDA has cited significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma, raising concerns about the reliability of testing records and the oversight of drugs distributed to the U.S. market. The findings, detailed in a [just-posted Form FDA 483](https://www.fda.gov/media/191198/download?ref=fdaweb.com), follow a 2/1-concluded inspection of Aurobindo’s Unit VII finished drug product facility in Telangana, India. Investigators documented deficiencies across complaint handling, stability testing, batch record review, laboratory controls, microbiology practices, and employee training.

FDA investigators said the company failed to adequately investigate multiple U.S. market complaints alleging lack of effect (LOE). In several cases spanning 2025 and early 2026, complaint files were closed without completing the required number of follow-up attempts or documenting justification for the abbreviated investigations. The agency also noted that the firm had received additional LOE complaints and adverse event reports but did not consistently conduct thorough follow-up or root cause analysis.

One of the most serious observations involved impurity levels and stability trends. The company had previously recalled certain batches after detecting impurity content above an acceptable intake (AI) limit. However, FDA found that three additional batches showed impurity levels near the AI threshold during initial testing, and two of those batches continued to trend upward at the 12-month stability interval.

Despite data suggesting the products could become out-of-specification (OOS) before expiry, the quality unit allegedly kept the batches on the U.S. market without conducting additional analyses or providing scientific justification. In some instances, stability studies were delayed by several months, with final time-point testing conducted after product expiry. Investigators warned that such delays could result in subpotent drug products remaining in distribution.

FDA cited systemic weaknesses in the quality unit’s oversight. In one instance, a senior in-process quality assurance executive signed off on batch record verification steps that had not been completed, including confirmation that certificates of analysis matched specifications and that investigations were closed.

The agency also found blank, unused checklist copies attached to approved batch production records without documented explanation. In another case, more copies of a controlled quality assurance form were issued than authorized under document control procedures.

Additionally, the inspection documented multiple data integrity concerns. In the microbiology laboratory, an assistant manager was observed signing documents with dates that did not correspond to the actual signing date. After initially denying backdating, the employee later acknowledged doing so.

Separately, FDA found that electronic dissolution test reports generated by standalone Electrolab equipment were neither reviewed nor printed by the quality unit. Electronic records lacked required metadata such as batch numbers and analytical reference numbers. In some cases, dissolution test durations exceeded specified limits, but the discrepancies were not reconciled in the analytical packages.

The inspection underscores the agency’s continued focus on data integrity and quality system robustness at overseas finished dosage manufacturers supplying U.S. patients.