FDA Inspection
Medical Engineering Laboratories, Inc.Medical Engineering Laboratories, Inc. – FDA Inspection, Apr 23, 2015
Record Details
This FDA Inspection record concerns Medical Engineering Laboratories, Inc., with an inspection on April 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 23, 2015
- Product Type
- Devices
View Company Profile
ID · ac319042-9722-4458-b9e2-0c4c1b88d1c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930734
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Medical Engineering Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Engineering Laboratories, Inc.
- FDA Inspection 717836 - 2011-03-22
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