FDA Inspection 752507 — Command Medical Products LLC

Command Medical Products LLC — FEI 1526611

The FDA completed an inspection of Command Medical Products LLC on October 25, 2011 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
October 25, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Ormond Beach, FL (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures