FDA Inspection 782202 — Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi
The FDA completed an inspection of Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi on May 3, 2012 in Istanbul. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 3, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Istanbul (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1924 | 21 CFR 211.166(a)(5) | Testing of reconstituted drugs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |