FDA Inspection 1083741 — Saalt, LLC

Saalt, LLC — FEI 3014276660

The FDA completed an inspection of Saalt, LLC on March 8, 2019 in Boise, ID. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 8, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Boise, ID (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
383721 CFR 820.25(b)Training records