FDA Inspection
Intersurgical Ltd. - GuernseyIntersurgical Ltd. - Guernsey – FDA Inspection, May 17, 2012
Record Details
This FDA Inspection record concerns Intersurgical Ltd. - Guernsey, with an inspection on May 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 17, 2012
- Product Type
- Devices
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ID · ee2a132a-df23-4e20-b42d-47549592f6e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 785680
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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