FDA Inspection
Bioretec LtdBioretec Ltd – FDA Inspection, Feb 22, 2018
Record Details
This FDA Inspection record concerns Bioretec Ltd, with an inspection on February 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · 4ff17489-5157-427b-98ef-bcd149210430
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044937
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Bioretec Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | NAI | Office of Inspections and Investigations | Postmarket Assurance: Medical Devices |
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