RenatiLabs IncAugust 12, 2022

FDA 483 - RenatiLabs Inc - August 12, 2022

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An FDA inspection of RenatiLabs Inc in Erlanger, KY, a manufacturer of WJMAX umbilical cord tissue product, revealed significant deficiencies in aseptic processing and quality control. The firm failed to adequately validate its aseptic manufacturing process, establish proper production controls, and conduct necessary stability and sterility testing. Additionally, environmental monitoring and cleaning procedures in aseptic areas were found to be inadequate.

Company: RenatiLabs Inc
Inspection Date: August 12, 2022
Product Type: Drugs
Office: Cincinnati District Office
People: Nisha C. Patel
Jennifer L. Sheehan

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ID · de40e7c6-42d4-456d-8058-42686f53bce7