FDA Inspection 1117120 — Scapa Tapes North America LLC

Scapa Tapes North America LLC — FEI 3015200795

The FDA completed an inspection of Scapa Tapes North America LLC on February 7, 2020 in Knoxville, 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
February 7, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Knoxville, TN (United States)

Citations

IDCFRDescription
200821 CFR 211.186(a)Written procedures followed
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements