FDA Inspection 1240100 — Diora Kimya Sanayi ve Ticaret Limited Sirketi
The FDA completed an inspection of Diora Kimya Sanayi ve Ticaret Limited Sirketi on May 31, 2024 in Gaziantep. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 31, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gaziantep (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |