Swiss American CDMO, LLCDecember 19, 2022

FDA 483 - Swiss American CDMO, LLC - December 19, 2022

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Swiss American CDMO, LLC in Carrollton, TX, a contract manufacturer, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate software and process validation, failures in corrective and preventive action procedures, and insufficient supplier management. One observation regarding software validation was a repeat finding from a previous inspection, indicating persistent issues.

Company: Swiss American CDMO, LLC
Inspection Date: December 19, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
Person: Terri E. Gibson

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ID · b90e1262-f76b-4f55-a5a8-e8db140a8545