FDA Inspection
Renishaw Mayfield SRenishaw Mayfield S – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Renishaw Mayfield S, with an inspection on June 12, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · cf7591f6-e7c0-42ea-82e2-60b37600989a
Inspection Facts
- Inspection number
- 1275706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.20(a)Records not kept
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Renishaw Mayfield S
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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