FDA Inspection
Bayer HealthCare, LLCBayer HealthCare, LLC – FDA Inspection, Dec 13, 2016
Record Details
This FDA Inspection record concerns Bayer HealthCare, LLC, with an inspection on December 13, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- James C. Lee (Issuing Officer)
- Stephanie A. Slater
View Company Profile
ID · dcc5f8f7-9883-4e90-b4b1-14258fc17a76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995350
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Bayer HealthCare, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2026 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| October 30, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 26, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bayer HealthCare, LLC
- FDA Inspection 1313442 - 2026-06-02
- FDA Inspection 1250181 - 2024-10-30
- FDA Inspection 1178420 - 2022-08-26
- FDA Inspection 1111955 - 2019-11-21
- FDA Inspection 1068508 - 2018-09-21
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