FDA Inspection 1315342 — Biopoly Llc
The FDA completed an inspection of Biopoly Llc on April 30, 2026 in Fort Wayne, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Wayne, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |