FDA Inspection 1226130 — Bimeda Pomona Inc.

Bimeda Pomona Inc. — FEI 2023614

The FDA completed an inspection of Bimeda Pomona Inc. on December 18, 2023 in Pomona, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 18, 2023
Fiscal Year
2024
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Pomona, CA (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
357321 CFR 211.101(b)Measured components for manufacturing