FDA Inspection 916583 — Tegra Medical (MS) LLC

Tegra Medical (MS) LLC — FEI 3008647423

The FDA completed an inspection of Tegra Medical (MS) LLC on February 27, 2015 in Hernando, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 27, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Hernando, MS (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures