FDA Inspection 753723 — Sterling Critical Products, LLC

Sterling Critical Products, LLC — FEI 3006490638

The FDA completed an inspection of Sterling Critical Products, LLC on Oct 3, 2011 in Minneapolis, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Oct 3, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Minneapolis, MN (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472121 CFR 820.70(g)(2)Periodic equipment inspections
313921 CFR 820.140Lack of or inadequate procedures for handling
315921 CFR 820.184DHR content
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures