FDA Inspection 751772 — Piedmont LLC

Piedmont LLC — FEI 1038960

The FDA completed an inspection of Piedmont LLC on October 17, 2011 in Gainesville, GA. 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
October 17, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gainesville, GA (United States)

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews