FDA WARNING_LETTER - Rapid Diagnostics, Division Of Mp Biomedicals, Llc - March 02, 2015

On August 24, 2015, the FDA issued a Warning Letter to Milan Panic, CEO of Rapid Diagnostics, Division of MP Biomedicals, Llc, following an inspection from February 19 to March 2, 2015. The inspection revealed that the firm manufactures in vitro diagnostic devices, including the OneStep Myoglobin RapidCard InstaTest.

The OneStep Myoglobin RapidCard InstaTest device was found to be adulterated because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption (IDE). It was also misbranded because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k) and 21 C.F.R. 807.81(a)(3)(ii).

Furthermore, the firm failed to fulfill annual registration and device listing requirements for fiscal year 2015. Specifically, devices such as OneStep Myoglobin RapidCard InstaTest, Troponin I Serum/Whole Blood RapidCard InstaTest, Fecal Occult Blood Test Card, and RapidPSA Test were not listed. This renders all unlisted devices misbranded under section 502(o) of the Act.

Rapid Diagnostics must take prompt action to correct these violations. Failure to do so may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The