FDA Inspection
HUNTER SCIENTIFIC LTDHUNTER SCIENTIFIC LTD – FDA Inspection, Jul 30, 2026
Record Details
This FDA Inspection record concerns HUNTER SCIENTIFIC LTD, with an inspection on July 30, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 60c95a29-d551-4ad8-ae61-4c4b9dab5772
Inspection Facts
- Inspection number
- 1328562
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.5.8Procedures for product identification not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of HUNTER SCIENTIFIC LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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