FDA Inspection 1117374 — Ansh Labs, LLC

Ansh Labs, LLC — FEI 3008198807

The FDA completed an inspection of Ansh Labs, LLC on February 10, 2020 in Webster, TX. 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
February 10, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Webster, TX (United States)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures