FDA Inspection
Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna SubesiMustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi – FDA Inspection, May 3, 2012
Record Details
This FDA Inspection record concerns Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi, with an inspection on May 3, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 3, 2012
- Product Type
- Drugs
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ID · ba1c2517-4c76-4d47-b2fc-9f3c069d2cab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 782202
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(5)Testing of reconstituted drugs
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Other FDA inspections of Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mustafa Nevzat Ilac Sanayi, A.S. - Yenibosna Subesi
- FDA Inspection 591941 - 2009-06-01
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