FDA Inspection 855042 — Rockford Acquisition Company, LLC

Rockford Acquisition Company, LLC — FEI 3007203968

The FDA completed an inspection of Rockford Acquisition Company, LLC on November 12, 2013 in Loves Park, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 12, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Loves Park, IL (United States)

Citations

IDCFRDescription
233921 CFR 820.22Quality Audit/Reaudit - documentation
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures