FDA Inspection 1072971 — Letco Medical LLC

Letco Medical LLC — FEI 3003063918

The FDA completed an inspection of Letco Medical LLC on November 29, 2018 in Decatur, AL. 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
November 29, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Decatur, AL (United States)

Citations

IDCFRDescription
360321 CFR 211.160(b)Scientifically sound laboratory controls