FDA Inspection
BAYER PHARMA, AGBAYER PHARMA, AG – FDA Inspection, Sep 24, 2019
Record Details
This FDA Inspection record concerns BAYER PHARMA, AG, with an inspection on September 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f4d6e717-a64d-42ca-931d-40fe4ad01598
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102816
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| July 3, 2017 | Not classified | Office of Inspections and Investigations | |
| January 24, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 13, 2014 | VAI | 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 1023408 - 2017-07-03
- FDA Inspection 1001127 - 2017-01-24
- FDA Inspection 889209 - 2014-05-13
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