FDA Inspection 1049791 — Unit Dose Services, LLC

Unit Dose Services, LLC — FEI 3010164341

The FDA completed an inspection of Unit Dose Services, LLC on April 26, 2018 in Dania, FL. 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
April 26, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dania, FL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
201121 CFR 211.188(a)Accurate reproduction