FDA Inspection 1086657 — Phelan Mfg Corp

Phelan Mfg Corp — FEI 2126376

The FDA completed an inspection of Phelan Mfg Corp on April 18, 2019 in Minneapolis, MN. 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 18, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Minneapolis, MN (United States)

Citations

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