FDA Inspection
Northeast Resins & Silicones, LLCNortheast Resins & Silicones, LLC – FDA Inspection, Sep 10, 2009
Record Details
This FDA Inspection record concerns Northeast Resins & Silicones, LLC, with an inspection on September 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 10, 2009
- Product Type
- Devices
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ID · f295c78b-3090-421e-bb04-36a1551222db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611540
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)General
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)(3)Standards or codes
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Northeast Resins & Silicones, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Northeast Resins & Silicones, LLC
- FDA Inspection 1279023 - 2025-08-19
- FDA Inspection 1177800 - 2022-08-16
- FDA Inspection 994032 - 2016-12-13
- FDA Inspection 837694 - 2013-06-18
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