FDA Inspection
North American Rescue LLC.North American Rescue LLC. – FDA Inspection, Jun 19, 2015
Record Details
This FDA Inspection record concerns North American Rescue LLC., with an inspection on June 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- North American Rescue LLC.
- Inspection Date
- June 19, 2015
- Product Type
- Devices
View Company Profile
ID · d11628a1-7e1d-4ac2-8c50-9071ac5659ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 931292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
Full citation text and observation details available on the Dashboard.
Other FDA inspections of North American Rescue LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2026 | NAI | Atlanta District Office | Postmarket Assurance: Devices |
| January 31, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for North American Rescue LLC.
- FDA Inspection 1309560 - 2026-03-27
- FDA Inspection 1118525 - 2020-01-31
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