FDA Inspection 718221 — Peace Medical Inc.
The FDA completed an inspection of Peace Medical Inc. on April 5, 2011 in Wharton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wharton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |