FDA Inspection 825133 — Peter Schiff Enterprises

Peter Schiff Enterprises — FEI 1000112898

The FDA completed an inspection of Peter Schiff Enterprises on April 12, 2013 in Cookeville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 12, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Cookeville, TN (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
341521 CFR 820.22Quality Audit/Reaudit - conducted
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures