FDA Inspection 904579 — Biogenesis, Inc

Biogenesis, Inc — FEI 3004933570

The FDA completed an inspection of Biogenesis, Inc on November 18, 2014 in Paterson, NJ. 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
November 18, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Paterson, NJ (United States)

Citations

IDCFRDescription
432121 CFR 211.101(b)Identification of new containers