FDA Inspection 926606 — InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals, Inc. — FEI 3003950641

The FDA completed an inspection of InvaGen Pharmaceuticals, Inc. on May 26, 2015 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed