FDA Inspection 1073401 — Command Medical Products LLC

Command Medical Products LLC — FEI 1526611

The FDA completed an inspection of Command Medical Products LLC on November 30, 2018 in Ormond Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 30, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Ormond Beach, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures