483
Trigon America LLCTrigon America LLC – FDA 483, Feb 13, 2019
Record Details
Trigon International LLC, a medical device manufacturer in Aurora, IL, was inspected by the FDA from February 5-13, 2019. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for finished device acceptance, unvalidated manufacturing processes, and failures in their corrective and preventive action (CAPA) system. Repeat observations were noted for CAPA file maintenance and complaint handling, indicating persistent quality control issues.
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ID · af24e25d-9415-4e2b-90e5-2072ad41b86b
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