FDA Inspection
New England Medical Corp.New England Medical Corp. – FDA Inspection, Dec 19, 2016
Record Details
This FDA Inspection record concerns New England Medical Corp., with an inspection on December 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fffd6884-bcde-4944-8113-b68b153663de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999600
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New England Medical Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2012 | 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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