FDA Inspection 1216786 — PT Solutions LLC
The FDA completed an inspection of PT Solutions LLC on Aug 10, 2023 in Brunswick, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brunswick, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |