FDA Inspection 1108091 — Celestica Oregon, LLC.

Celestica Oregon, LLC. — FEI 3009039038

The FDA completed an inspection of Celestica Oregon, LLC. on October 25, 2019 in Portland, OR. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Portland, OR (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
316021 CFR 820.184Lack of or inadequate DHR procedures