UEEC IMO hired RCA to prep the company on packaging the PMA application for which the FDA requested third party testing information. To learn more about the reply review the following RCA podcast of basically how to reply to an OOS request.

https://www.rcainc.com/podcasts/lab-testing-p...tigations/

Hit the arrow under Lab Testing and OOS Investigations.
$5-$10+
Confidence grows!
Do your d/d.