FDA Inspection 880689 — Peter T. Pugliese MD and Associates

Peter T. Pugliese MD and Associates — FEI 3008160591

The FDA completed an inspection of Peter T. Pugliese MD and Associates on May 30, 2014 in Bernville, PA. 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: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 30, 2014
Fiscal Year
2014
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Bernville, PA (United States)

Citations

IDCFRDescription
122721 CFR 211.67(c)Cleaning/maintenance records not kept
189021 CFR 211.165(e)Test methods
203321 CFR 211.194(c)Testing and standardization of standards et. al.
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action