FDA Inspection
Saalt, LLCSaalt, LLC – FDA Inspection, Mar 8, 2019
Record Details
This FDA Inspection record concerns Saalt, LLC, with an inspection on March 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f929da7a-b8ff-48f8-88e5-90c4f4dff261
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1083741
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Saalt, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Saalt, LLC
- FDA Inspection 1148532 - 2021-07-29
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