FDA Inspection 1225985 — Den-Mat Holdings, LLC

Den-Mat Holdings, LLC — FEI 2018957

The FDA completed an inspection of Den-Mat Holdings, LLC on December 7, 2023 in Lompoc, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 7, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lompoc, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
431421 CFR 211.84(d)(2)Reports of Analysis (Components)