Fenwal International, Inc.September 18, 2024

FDA 483 - Fenwal International, Inc. - September 18, 2024

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Record Details

Fenwal International, Inc. in Maricao, PR, was inspected and received a Form 483 with seven observations. The inspection revealed significant issues including inadequately designed and maintained equipment, biological growth in critical environments, facility disrepair, and deficiencies in laboratory controls and environmental monitoring. Additionally, the firm failed to maintain adequate annual product reviews and handwashing facilities.

Company: Fenwal International, Inc.
Inspection Date: September 18, 2024
Product Type: Biologics
Office: San Juan District Office
People: Lisoida Perez
Kody T Aikman
Lizaida Perez (FDA_PERSONNEL)
Cody D. Rickman
Scott T. Ballard

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ID · 9da39e05-129f-4655-9b84-85216d00b812