FDA Inspection
Bayer HealthCare, LLCBayer HealthCare, LLC – FDA Inspection, Feb 5, 2009
Record Details
This FDA Inspection record concerns Bayer HealthCare, LLC, with an inspection on February 5, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayer HealthCare, LLC
- Inspection Date
- February 5, 2009
- Product Type
- Drugs
View Company Profile
ID · 4f903f1a-ce12-4fb3-8543-43922fb13d0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 565029
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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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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