FDA Inspection 1089006 — Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. — FEI 1217052

The FDA completed an inspection of Smiths Medical ASD, Inc. on May 9, 2019 in Keene, NH. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 9, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Keene, NH (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures