FDA Inspection
Evonik CorporationEvonik Corporation – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Evonik Corporation, with an inspection on August 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 908baa29-46f3-427c-955f-b43339c03774
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063207
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Evonik Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2024 | VAI | New Orleans District Office | Drug Quality Assurance |
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