483
AIRIS PHARMA PRIVATE LIMITEDAIRIS PHARMA PRIVATE LIMITED – FDA 483, Feb 3, 2024
Record Details
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.
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ID · 66ecbe88-de3d-4a60-a3a1-01ae7edc9897
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