FDA Inspection 756040 — Lincare Incorporated

Lincare Incorporated — FEI 1219527

The FDA completed an inspection of Lincare Incorporated on Dec 7, 2011 in West Hartford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 7, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Hartford, CT (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
202621 CFR 211.192Quality control unit review of records