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 Devices and Radiological Health, covering devices.
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ID · 6baafbe7-3824-4ccc-9fba-a9266f03d4a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994423
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Bayer Healthcare, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayer Healthcare, LLC
- FDA Inspection 783411 - 2012-04-19
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