Question 19 4 points Luke went to an outside training session to become a certified quality auditor. He received a training certificate for passing the course but later lost the certificate before turning it into HR to be placed in his training file. Two months later an FDA inspector auditing the site cites the firm for a violation because Luke is not a train auditor under 21CFR 820.25-Training' after reviewing Luke's training file is the FDA inspector correct? Yes No Save Ans Question 24 4 points Your company owns two manufacturing sites one in Romania and the other in the US each called ABC Company and each with its own quality system procedures and policies. The US site is launching a new class II pulse oximeter monitor and they use a measurement board that they get fromtheir Romanian manufacturing plant. Does the US need to apply FDA QSR purchasing controls to the procurement of the board? Yes No