FDA 483 - Auriga Research Private Limited - February 06, 2026

Auriga Research Private Limited, a contract testing laboratory in Bengaluru, India, was cited for significant deficiencies in laboratory controls, data integrity, and quality unit procedures. The inspection revealed failures to document microbiological testing, inadequate investigations into out-of-specification results, and a general lack of adherence to written procedures, indicating systemic issues in quality control.