FDA WARNING_LETTER - Auriga Research Private Limited - February 06, 2026

The FDA issued a warning letter to Auriga Research Pvt. Ltd. following an inspection of its contract testing laboratory in Bengaluru, India, conducted from February 4 to 6, 2026. The evaluation identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering drug products tested at the facility adulterated under the Federal Food, Drug, and Cosmetic Act. The main violations involve failures in data integrity and quality control oversight. Specifically, the laboratory did not maintain complete or contemporaneous records, with investigators noting blank spaces on raw data sheets for microbial testing. Furthermore, the firm"s Quality Unit failed to properly investigate out-of-specification results. Instead of identifying root causes, the laboratory engaged in "testing into compliance"—repeatedly testing samples until a passing result was achieved and disregarding initial failures without scientific justification. To rectify these issues, the FDA mandates that Auriga Research hire an independent consultant to overhaul their quality systems. Required actions include a comprehensive assessment of laboratory practices, a retrospective review of all out-of-specification results for U.S.-bound products over the last three years, and the implementation of a robust system for sample tracking and documentation. The company must provide a detailed response within 15 business days. Failure to address these concerns may lead the FDA to withhold drug approvals or block the importation of products tested by the firm.