FDA Inspection 1268699 — Prentke Romich Company
The FDA completed an inspection of Prentke Romich Company on May 1, 2025 in Wooster, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 1, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wooster, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |