FDA Inspection 1007636 — Oxford Performance Materials, Inc.
The FDA completed an inspection of Oxford Performance Materials, Inc. on April 7, 2017 in South Windsor, CT. 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
- April 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- South Windsor, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3115 | 21 CFR 820.70(h) | Use and removal, Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |