FDA Inspection
Bayer Weimar GmbH und Co. KGBayer Weimar GmbH und Co. KG – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Bayer Weimar GmbH und Co. KG, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2dea6029-e51c-456e-b848-e0b82a40b1a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101920
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Bayer Weimar GmbH und Co. KG
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 24, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 5, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayer Weimar GmbH und Co. KG
- FDA Inspection 1274501 - 2022-11-24
- FDA Inspection 948310 - 2015-11-05
- FDA Inspection 805216 - 2012-10-19
- FDA Inspection 636510 - 2009-12-04
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