FDA Inspection
Arch Medical Solutions - SeabrookArch Medical Solutions - Seabrook – FDA Inspection, Aug 7, 2017
Record Details
This FDA Inspection record concerns Arch Medical Solutions - Seabrook, with an inspection on August 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Abby E. Pelletier (Issuing Officer)
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ID · 10151b0e-7a7b-4006-b597-c0ab713d8a7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021652
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Arch Medical Solutions - Seabrook
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 18, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arch Medical Solutions - Seabrook
- FDA Inspection 1280080 - 2025-08-06
- FDA Inspection 1164041 - 2022-02-18
- FDA Inspection 948441 - 2015-10-27
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