FDA Inspection 1326218 — Bionix, Llc
The FDA completed an inspection of Bionix, Llc on Jul 14, 2026 in Maumee, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 14, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Maumee, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |
| 23140 | ISO 13485:2016 Clause 7.4.1 | Supplier evaluation and selection criteria do not include required elements |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |