FDA Inspection 1335526 — Precision Medical Technologies
The FDA completed an inspection of Precision Medical Technologies on Sep 11, 2026 in N Manchester, IN. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- N Manchester, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23157 | ISO 13485:2016 Clause 7.5.1 | Medical device or batch records not adequate |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |