FDA Inspection
New England Medical Corp.New England Medical Corp. – FDA Inspection, Apr 27, 2012
Record Details
This FDA Inspection record concerns New England Medical Corp., with an inspection on April 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- New England Medical Corp.
- Inspection Date
- April 27, 2012
- Product Type
- Devices
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ID · a6fa734b-df95-494e-80a5-6a6a117018c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779593
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of New England Medical Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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