FDA Inspection 1203750 — O&M HALYARD INC

O&M HALYARD INC — FEI 3014421917

The FDA completed an inspection of O&M HALYARD INC on April 27, 2023 in Alpharetta, GA. 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
April 27, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Alpharetta, GA (United States)

Citations

IDCFRDescription
73221 CFR 803.50(a)(2)Individual Report of Malfunction