FDA Inspection
Synergy Health Sterilization UK LimitedSynergy Health Sterilization UK Limited – FDA Inspection, Jun 4, 2026
Record Details
This FDA Inspection record concerns Synergy Health Sterilization UK Limited, with an inspection on June 4, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 4, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 7f8f07b0-6853-4c35-9843-94337ad7ce57
Inspection Facts
- Inspection number
- 1321410
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synergy Health Sterilization UK Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synergy Health Sterilization UK Limited
- FDA Inspection 773000 - 2012-02-01
- FDA Inspection 545236 - 2008-10-14
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