FDA Inspection 706049 — Unilever HPC

Unilever HPC — FEI 1210994

The FDA completed an inspection of Unilever HPC on Jan 14, 2011 in Clinton, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 14, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clinton, CT (United States)

Citations

IDCFRDescription
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
192021 CFR 211.166(a)(3)Valid stability test methods
192621 CFR 211.166(b)Adequate number of batches on stability