483
Milliken Healthcare Products, LLCMilliken Healthcare Products, LLC – FDA 483, Jul 30, 2026
Record Details
An FDA inspection of Milliken Healthcare Products, LLC in Spartanburg, SC, a manufacturer, revealed a significant issue with their corrective and preventive action (CAPA) system. The firm failed to adequately address the root cause of compromised stability samples, which were critical for verifying product efficacy, and did not initiate a new CAPA to prevent recurrence. This indicates a breakdown in their quality system regarding nonconformity resolution.
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- Atlanta District Office
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ID · 3e60420f-cca5-4482-980d-5bef8b27b3d5
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