On Monday, February 6th, Myriad Fiber Imaging was audited by the United States Food and Drug Administration (the FDA). This audit was not conducted as a result of any complaints from a customer, nor because of any defective products manufactured by Myriad. This was a standard, random audit routinely initiated by the FDA for any company registered with their organization. Myriad is registered with the FDA, and had last been audited by them about 10 years ago; so we were due.
During the audit, the auditor reviewed our quality system and procedures including: the quality manual, internal audits, shipping & receiving processes, management review meeting minutes, CAPA’s, equipment calibration, and training records for our employees. He also examined numerous documented records that verified that our procedures were in place and being used effectively.
At the completion of our FDA audit, the auditor was satisfied that Myriad had a robust quality system in place, and that the employees understood the procedures, and implemented them on a day to day basis. The auditor didn’t find any major non-compliance, and saw no reason to issue any 483’s. An official report will be issued by the FDA in a few weeks; when we will post it on this website.