FDA Inspection
Beeken Biomedical, LLCBeeken Biomedical, LLC – FDA Inspection, Jul 8, 2021
Record Details
This FDA Inspection record concerns Beeken Biomedical, LLC, with an inspection on July 8, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Beeken Biomedical, LLC
- Inspection Date
- July 8, 2021
- Product Type
- Devices
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ID · 046e5dee-958c-4d65-85c2-87cadd88277f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1145721
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Beeken Biomedical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Beeken Biomedical, LLC
- FDA Inspection 1034046 - 2017-11-07
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