701533
Healgen Scientific LLC — FEI 3003204823
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 23, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Swedesboro, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 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 |