FDA Inspection
Medical Supplies CorporationMedical Supplies Corporation – FDA Inspection, Jul 11, 2011
Record Details
This FDA Inspection record concerns Medical Supplies Corporation, with an inspection on July 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Supplies Corporation
- Inspection Date
- July 11, 2011
- Product Type
- Devices
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ID · 6deb8e27-1a3c-4c34-8bf4-cd7519fe18e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 734154
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of Medical Supplies Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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