730758

Ranbaxy Inc. — FEI 3003476632

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 22, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Princeton, NJ (United States)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
673621 CFR 314.80(c)(1)(ii)Submission of report follow-up
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report