FDA Inspection
Arch Medical Solutions - ElkhartArch Medical Solutions - Elkhart – FDA Inspection, Dec 18, 2024
Record Details
This FDA Inspection record concerns Arch Medical Solutions - Elkhart, with an inspection on December 18, 2024, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- December 18, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 6405970e-1fb4-45e2-9fdf-7e36a286e643
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1257334
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Arch Medical Solutions - Elkhart
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arch Medical Solutions - Elkhart
- FDA Inspection 1148583 - 2021-08-06
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