FDA Inspection 654704 — Non-Invasive Monitoring Systems, Inc.

Non-Invasive Monitoring Systems, Inc. — FEI 2431353

The FDA completed an inspection of Non-Invasive Monitoring Systems, Inc. on March 25, 2010 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 25, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Miami, FL (United States)

Citations

IDCFRDescription
247021 CFR 820.30(c)Design input procedures - appropriateness
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements