867106
Cytophil, Inc. — FEI 3007225376
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 13, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- East Troy, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 4202 | 21 CFR 806.10(c)(9) | Device number, identification |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 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 |