FDA Inspection 1250169 — Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi
The FDA completed an inspection of Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi on Sep 20, 2024 in Kirac. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kirac (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 |