FDA Inspection 1034952 — PureTek Corporation

PureTek Corporation — FEI 1000125324

The FDA completed an inspection of PureTek Corporation on December 15, 2017 in San Fernando, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Fernando, CA (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance