FDA Inspection
Bayer HealthCare LLCBayer HealthCare LLC – FDA Inspection, Aug 11, 2017
Record Details
This FDA Inspection record concerns Bayer HealthCare LLC, with an inspection on August 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 59f7e0b2-9b69-43b4-9e27-85b907d8700a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021532
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Bayer HealthCare LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayer HealthCare LLC
- FDA Inspection 1308052 - 2026-05-22
- FDA Inspection 1209567 - 2023-06-07
- FDA Inspection 1199413 - 2023-02-01
- FDA Inspection 852054 - 2013-10-18
- FDA Inspection 739275 - 2011-07-21
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