FDA 483 - AIRIS PHARMA PRIVATE LIMITED - February 03, 2024

AIRIS PHARMA PRIVATE LIMITED, a contract testing laboratory in Hyderabad, India, was cited by the FDA for significant deficiencies within its quality control unit. The inspection revealed a lack of written procedures for reporting to the agency, oversight of contract organizations, and reviewer qualification. Additionally, documentation for a stability chamber requalification study was found to be incomplete.