1250169
Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi — FEI 3018589922
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Esenyurt (Turkey)
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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |