FDA Inspection
Evonik Operations GmbHEvonik Operations GmbH – FDA Inspection, Dec 12, 2014
Record Details
This FDA Inspection record concerns Evonik Operations GmbH, with an inspection on December 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Evonik Operations GmbH
- Inspection Date
- December 12, 2014
- Product Type
- Drugs
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ID · c47f05c2-002b-403f-a194-bf76d1a416b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909929
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Evonik Operations GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Evonik Operations GmbH
- FDA Inspection 1289284 - 2024-06-27
- FDA Inspection 1122166 - 2020-02-18
- FDA Inspection 772140 - 2012-02-14
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