483
Swiss American CDMO, LLCSwiss American CDMO, LLC – FDA 483, Dec 19, 2022
Record Details
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.
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ID · b90e1262-f76b-4f55-a5a8-e8db140a8545
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