1203106
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conyers, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |