FDA Inspection 744738 — Linde Gas & Equipment Inc.

Linde Gas & Equipment Inc. — FEI 1822933

The FDA completed an inspection of Linde Gas & Equipment Inc. on September 16, 2011 in Lincoln Park, MI. 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
September 16, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lincoln Park, MI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action