FDA Inspection
Mediwatch Uk LtdMediwatch Uk Ltd – FDA Inspection, Nov 4, 2011
Record Details
This FDA Inspection record concerns Mediwatch Uk Ltd, with an inspection on November 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mediwatch Uk Ltd
- Inspection Date
- November 4, 2011
- Product Type
- Devices
View Company Profile
ID · a6bc45a6-3e91-4f95-9d81-2ea4b3c8a545
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 761730
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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