FDA Inspection 1199379 — Micro Distributing I I, Ltd

Micro Distributing I I, Ltd — FEI 3008416529

The FDA completed an inspection of Micro Distributing I I, Ltd on March 7, 2023 in Belton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 7, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Belton, TX (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
63021 CFR 803.17Lack of Written MDR Procedures