FDA Inspection 801860 — Summit Medical, LLC

Summit Medical, LLC — FEI 3008719017

The FDA completed an inspection of Summit Medical, LLC on September 7, 2012 in Eagan, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 7, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Eagan, MN (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
312321 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures