FDA Inspection 1024944 — Belmora LLC

Belmora LLC — FEI 3009442527

The FDA completed an inspection of Belmora LLC on September 13, 2017 in Arlington, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 13, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Arlington, VA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683021 CFR 314.80(c)(2)Interval
891221 CFR 314.81(b)(2)Timely submission