# Biopoly Llc – FDA 483, Apr 30, 2026

Source: https://www.keypedia.com/records/483/biopoly-llc/52bac5c5-f3f0-47a3-b912-39845fab718e

> FDA 483 for Biopoly Llc on April 30, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biopoly Llc
- Inspection Date: 2026-04-30
- Product Type: device
- Office Name: Detroit District Office
- Summary: 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.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/biopoly-llc/426b1b1f-4d7b-41aa-969e-761b0ca34775

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03