FDA Inspection 896877 — Hearing Lab Technology, LLC

Hearing Lab Technology, LLC — FEI 2523532

The FDA completed an inspection of Hearing Lab Technology, LLC on September 12, 2014 in Bristol, PA. 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
September 12, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Bristol, PA (United States)

Citations

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