FDA Inspection 967721 — B & G Labs, Inc

B & G Labs, Inc — FEI 1943943

The FDA completed an inspection of B & G Labs, Inc on February 10, 2016 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 10, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Louis, MO (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
192021 CFR 211.166(a)(3)Valid stability test methods
431421 CFR 211.84(d)(2)Reports of Analysis (Components)