FDA Inspection 1084158 — Gulden Ophthalmics

Gulden Ophthalmics — FEI 2518410

The FDA completed an inspection of Gulden Ophthalmics on March 14, 2019 in Elkins Park, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 14, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Elkins Park, PA (United States)