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# Auriga Research CGMP Violations
- URL: https://www.fdaweb.com/auriga-research-cgmp-violations/
- Published: 2026-08-19T12:00:00.000Z
- Updated: 2026-09-14T12:06:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161650

A 2/4-2/6 FDA inspection at the Auriga Research contract testing laboratory in Bengaluru, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026?ref=fdaweb.com) says the specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and records; and
- failure to establish adequate written responsibilities and procedures applicable to the quality control unit.

The letter says FDA considers contractors to be extensions of a manufacturer’s facility and Auriga’s failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs it tests for its clients. The agency recommends the firm engage a qualified consultant to assist it in meeting CGMP requirements.

Auriga was told to address the violations “without delay,” ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence.