United Health Products Inc (UEEC)

[shoondale]

1. Failure to submit an IDE application to FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required [21 CFR 812.20(a)(1) and (2).

http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/united-health-products-inc-697777-03242025