FDA Inspection 996561 — Miami Device Solutions, LLC.

Miami Device Solutions, LLC. — FEI 3009222247

The FDA completed an inspection of Miami Device Solutions, LLC. on October 26, 2016 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 26, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Miami, FL (United States)

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures