FDA Inspection
Northeast Scientific Inc.Northeast Scientific Inc. – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Northeast Scientific Inc., with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7e14697d-5ca9-4a88-a74e-9df7f75d7798
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042605
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Northeast Scientific Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 8, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Northeast Scientific Inc.
- FDA Inspection 1177884 - 2022-07-26
- FDA Inspection 878627 - 2014-05-07
- FDA Inspection 774237 - 2012-03-08
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