1014220
Winchester Laboratories, LLC — FEI 3003036307
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Delray Beach, FL (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 |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |