615531
Applied Laboratories, Inc. — FEI 1831301
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |