FDA Inspection 682974 — Bryant Ranch PrePack

Bryant Ranch PrePack — FEI 1000519407

The FDA completed an inspection of Bryant Ranch PrePack on September 29, 2010 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 29, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Burbank, CA (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
172621 CFR 211.86Rotation of components/containers/closures
194221 CFR 211.180(e)Records reviewed annually
432121 CFR 211.101(b)Identification of new containers