FDA Inspection 713130 — Battle Creek Equipment Co.

Battle Creek Equipment Co. — FEI 1833125

The FDA completed an inspection of Battle Creek Equipment Co. on March 1, 2011 in Fremont, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 1, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Fremont, IN (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
316021 CFR 820.184Lack of or inadequate DHR procedures
333121 CFR 820.181DMR - not or inadequately maintained
341521 CFR 820.22Quality Audit/Reaudit - conducted