FDA Inspection 1249294 — Precision Medical Technologies, Inc.
The FDA completed an inspection of Precision Medical Technologies, Inc. on Sep 6, 2024 in Warsaw, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 6, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |