FDA Inspection 969967 — Aptyx Charlotte, LLC

Aptyx Charlotte, LLC — FEI 3011324393

The FDA completed an inspection of Aptyx Charlotte, LLC on March 21, 2016 in Charlotte, NC. 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
March 21, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained