FDA Inspection
BAYER PHARMA, AGBAYER PHARMA, AG – FDA Inspection, May 13, 2014
Record Details
This FDA Inspection record concerns BAYER PHARMA, AG, with an inspection on May 13, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BAYER PHARMA, AG
- Inspection Date
- May 13, 2014
- Product Type
- Drugs
View Company Profile
ID · 62dcd89d-3755-4ff0-bfd0-1cd68e1ec209
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 889209
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of BAYER PHARMA, AG
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 27, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 24, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 3, 2017 | Not classified | Office of Inspections and Investigations | |
| January 24, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BAYER PHARMA, AG
- FDA Inspection 1282736 - 2024-06-06
- FDA Inspection 1239178 - 2021-08-27
- FDA Inspection 1102816 - 2019-09-24
- FDA Inspection 1023408 - 2017-07-03
- FDA Inspection 1001127 - 2017-01-24
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