820597
Helena Laboratories, Corp. — FEI 1618982
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beaumont, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |