FDA Inspection
TCM Supply CorporationTCM Supply Corporation – FDA Inspection, Apr 25, 2012
Record Details
This FDA Inspection record concerns TCM Supply Corporation, with an inspection on April 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TCM Supply Corporation
- Inspection Date
- April 25, 2012
- Product Type
- Devices
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ID · 4ea0f35f-0c04-49b9-b6e5-6eb9138dcb13
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 779825
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Showing 10 of 12 citations.
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Other FDA inspections of TCM Supply Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TCM Supply Corporation
- FDA Inspection 838599 - 2013-06-18
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