FDA Inspection 1009929 — Union Agener Inc

Union Agener Inc — FEI 3003627565

The FDA completed an inspection of Union Agener Inc on March 31, 2017 in Augusta, GA. 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
March 31, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Augusta, GA (United States)

Citations

IDCFRDescription
187921 CFR 211.180(c)Records not made readily available to FDA
438321 CFR 211.198(b)(1)Written complaint record must include