FDA Inspection 952579 — Bio-Derm Laboratories, Inc

Bio-Derm Laboratories, Inc — FEI 1000117931

The FDA completed an inspection of Bio-Derm Laboratories, Inc on December 14, 2015 in Longview, TX. 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
December 14, 2015
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Longview, TX (United States)

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution
194221 CFR 211.180(e)Records reviewed annually
200821 CFR 211.186(a)Written procedures followed
430721 CFR 211.80(d)Status of Each Lot Identified