FDA Inspection 1229649 — Soft Touch Labs-GENERAL HEARING INSTRUMENTS

Soft Touch Labs-GENERAL HEARING INSTRUMENTS — FEI 2317393

The FDA completed an inspection of Soft Touch Labs-GENERAL HEARING INSTRUMENTS on May 3, 2024 in Harahan, LA. 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 3, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Harahan, LA (United States)

Citations

IDCFRDescription
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures