FDA Inspection
Deva Holding A.S. - Kartepe Uretim TesisleriDeva Holding A.S. - Kartepe Uretim Tesisleri – FDA Inspection, Jul 25, 2023
Record Details
This FDA Inspection record concerns Deva Holding A.S. - Kartepe Uretim Tesisleri, with an inspection on July 25, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5157f646-4421-4deb-bcb2-fc51310783bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210691
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Deva Holding A.S. - Kartepe Uretim Tesisleri
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Deva Holding A.S. - Kartepe Uretim Tesisleri
- FDA Inspection 1226333 - 2023-12-06
- FDA Inspection 941448 - 2015-07-30
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