FDA Inspection
Northeast Scientific Inc.Northeast Scientific Inc. – FDA Inspection, Mar 8, 2012
Record Details
This FDA Inspection record concerns Northeast Scientific Inc., with an inspection on March 8, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Northeast Scientific Inc.
- Inspection Date
- March 8, 2012
- Product Type
- Devices
View Company Profile
ID · 36066d89-029b-4407-8953-ef540d49ffcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774237
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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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 |
| February 23, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Northeast Scientific Inc.
- FDA Inspection 1177884 - 2022-07-26
- FDA Inspection 1042605 - 2018-02-23
- FDA Inspection 878627 - 2014-05-07
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