874866

Belleview 402 LLC — FEI 3005350897

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 1, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brooksville, FL (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
192621 CFR 211.166(b)Adequate number of batches on stability
241921 CFR 211.198(a)Complaint Handling Procedure
363921 CFR 211.204Returned drug procedures in writing and followed