FDA Inspection
Bioretec LtdBioretec Ltd – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns Bioretec Ltd, with an inspection on January 23, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9bbdbcc3-db5d-455b-bd15-19291a42cd23
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1259316
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of Bioretec Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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