FDA Inspection
Synergy Health Sterilisation UK LtdSynergy Health Sterilisation UK Ltd – FDA Inspection, Mar 9, 2023
Record Details
This FDA Inspection record concerns Synergy Health Sterilisation UK Ltd, with an inspection on March 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f65418bd-2f04-484a-8e01-d5bddec58699
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Synergy Health Sterilisation UK Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2017 | Not classified | Office of Inspections and Investigations | Project Evaluation: Devices |
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