FDA Inspection
Cascade Medical Enterprises, U.K., Ltd.Cascade Medical Enterprises, U.K., Ltd. – FDA Inspection, Jun 25, 2014
Record Details
This FDA Inspection record concerns Cascade Medical Enterprises, U.K., Ltd., with an inspection on June 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 25, 2014
- Product Type
- Devices
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ID · 6b3eb97f-91e6-4b7e-91f6-128543d7549b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885516
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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