FDA Inspection
Deva Holding Anonim SirketiDeva Holding Anonim Sirketi – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Deva Holding Anonim Sirketi, with an inspection on February 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e0fa8004-be6a-471c-8793-a92905111f21
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1079725
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)(3)Statement of Sample Weights and Measures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(d)Penicillin processing area not kept separate
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Deva Holding Anonim Sirketi
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 4, 2023 | VAI | Office of Inspections and Investigations | |
| September 23, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 18, 2019 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Deva Holding Anonim Sirketi
- FDA Inspection 1266089 - 2023-12-12
- FDA Inspection 1211420 - 2023-08-04
- FDA Inspection 1182272 - 2022-09-23
- FDA Inspection 1077842 - 2019-01-18
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