939733
SV Labs Corporation — FEI 2936586
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Watsonville, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |