FDA Inspection
HUNTER SCIENTIFIC LTDHUNTER SCIENTIFIC LTD – FDA Inspection, Dec 14, 2023
Record Details
This FDA Inspection record concerns HUNTER SCIENTIFIC LTD, with an inspection on December 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a6fda36d-78df-47c7-ad42-86fe8828dd97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1226551
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
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Other FDA inspections of HUNTER SCIENTIFIC LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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