1257696

Jubilant Cadista Pharmaceuticals — FEI 3017221809

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yardley, PA (United States)

Citations

IDCFRDescription
187921 CFR 211.180(c)Records not made readily available to FDA
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
202321 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
22921FDCA 582(b)(4)Systems in place to comply with verification requirements
359421 CFR 211.110(d)Rejected in-process materials not quarantined