FDA Inspection 1103405 — AltaThera Pharmaceuticals LLC

AltaThera Pharmaceuticals LLC — FEI 3013989010

The FDA completed an inspection of AltaThera Pharmaceuticals LLC on September 19, 2019 in Chicago, IL. 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
September 19, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chicago, IL (United States)

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility