875466
R.A. McNeil Company — FEI 3008534892
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 29, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |