483
MedLaunch IncorporatedFDA 483 - MedLaunch Incorporated - September 26, 2025
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Record Details
MedLaunch Incorporated, a contract manufacturer in Swannanoa, NC, received four observations during an FDA inspection. The inspection revealed deficiencies primarily related to process validation documentation, device history records, and the establishment and definition of controls over suppliers and products. These issues indicate a need for improved quality system procedures.
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