PRIMUS Sterilizer
FDA Audits the PRIMUS Great Bend Facility

 

The United States Food and Drug Administration (FDA) held an unannounced three day Surveillance Audit at the PRIMUS Great Bend facility from May 7 - 9, 2013. The purpose of the audit was to evaluate in depth whether PRIMUS was adhering to all requirements defined by the Food Drug and Cosmetic (FD&C) Act and related Acts.

At the end of the audit, no deficiencies were formally recorded on a FDA 483 (a very rare and extremely good thing!)

As a Class II medical device, all PRIMUS healthcare sterilizers are manufactured and marketed under federal law.

Violations of the law can result in civil and/or criminal penalties.

FDA auditors can audit any medical device manufacturer at will for any duration required.

PRIMUS' last FDA audit was at the two Omaha facilities in 2010.

All deficiencies of any significance are formally recorded on a FDA Form 483. The Form 483 deficiencies are public records and are posted on the FDA website for public scrutiny.