FDA Inspection 812984 — Birchwood Laboratories, LLC

Birchwood Laboratories, LLC — FEI 2182825

The FDA completed an inspection of Birchwood Laboratories, LLC on January 7, 2013 in Eden Prairie, MN. 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
January 7, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Eden Prairie, MN (United States)

Citations

IDCFRDescription
358521 CFR 211.110(a)Control procedures to monitor and validate performance