FDA Inspection
Bayer Bitterfeld GmbHBayer Bitterfeld GmbH – FDA Inspection, Apr 8, 2016
Record Details
This FDA Inspection record concerns Bayer Bitterfeld GmbH, with an inspection on April 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayer Bitterfeld GmbH
- Inspection Date
- April 8, 2016
- Product Type
- Drugs
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ID · 3858aea2-6afc-4f72-bb1c-ad632b63ebba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967375
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Bayer Bitterfeld GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayer Bitterfeld GmbH
- FDA Inspection 1272339 - 2024-06-19
- FDA Inspection 1124409 - 2019-07-10
- FDA Inspection 1048506 - 2018-03-23
- FDA Inspection 887887 - 2013-12-13
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