954304
Winder Laboratories, LLC — FEI 3008694072
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 3, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winder, GA (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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |