FDA Inspection 1023448 — Diagnostics Direct LLC

Diagnostics Direct LLC — FEI 3009178048

The FDA completed an inspection of Diagnostics Direct LLC on August 30, 2017 in Cape May Court House, NJ. 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
August 30, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cape May Court House, NJ (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures