FDA Inspection 928604 — Nice-Pak Products LLC

Nice-Pak Products LLC — FEI 1025121

The FDA completed an inspection of Nice-Pak Products LLC on June 3, 2015 in Smyrna, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Smyrna, TN (United States)

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution
192021 CFR 211.166(a)(3)Valid stability test methods