1177288
Fisher Pharmaceuticals Ltd. — FEI 3002750286
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 28, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tiberias Elite (Israel)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |