979342

Bell-More Labs, Inc. — FEI 1150023

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 26, 2016
Fiscal Year
2016
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Hampstead, MD (United States)

Citations

IDCFRDescription
142121 CFR 211.42(c)(10)Aseptic Processing Area
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair