FDA Inspection
Medical Equipment Direct, Inc.Medical Equipment Direct, Inc. – FDA Inspection, Aug 27, 2009
Record Details
This FDA Inspection record concerns Medical Equipment Direct, Inc., with an inspection on August 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 27, 2009
- Product Type
- Devices
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ID · d513b87a-d33b-4739-b682-c1583b4d4c0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607569
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Medical Equipment Direct, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Equipment Direct, Inc.
- FDA Inspection 914645 - 2015-02-19
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