1170685
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jiutepec (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |