483
Biopoly LlcBiopoly Llc – FDA 483, Apr 30, 2026
Record Details
Biopoly Llc in Fort Wayne, IN, a manufacturer of BioPoly Great Toe Implants, was cited for multiple significant deficiencies in its quality management system. The inspection revealed inadequate corrective and preventive actions, insufficient design and development inputs, deficient complaint handling, and poor control over nonconforming products and data analysis. These issues indicate systemic problems in ensuring product quality and safety.
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ID · 52bac5c5-f3f0-47a3-b912-39845fab718e
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