FDA EIR - Premier Biotech, Inc. - March 16, 2015

An FDA inspection of Premier Biotech, Inc. in Chanhassen, MN, conducted from January 6 to March 16, 2015, uncovered significant regulatory compliance issues. The company, a specification developer and distributor of Class II enzyme immunoassay drug test kits, was found to be distributing numerous devices without the necessary 510(k) pre-market clearance or CLIA waiver, as mandated by the Federal Food Drug and Cosmetic Act.

Primary violations included the sale of unapproved products like the OralTox saliva test system, Rapid EtG urine alcohol screening tests, and various drug test strips for substances such as K2/Spice, fentanyl, and alcohol, along with unauthorized modifications to approved cutoff levels. Additionally, many devices labeled "Forensic Use Only" were improperly sold to non-forensic customers, including employment agencies and employers, leading to misbranding and adulteration.

Although no FDA-483 was issued, management was informed of their obligation to obtain pre-market approval for all distributed devices and comply with applicable Quality System Regulations. Premier Biotech's management acknowledged non-compliance but stated intentions to pursue 510(k) clearance only for the OralTox product, requesting enforcement discretion for other unapproved items—a request the FDA did not grant. The firm was expected to rectify these deficiencies.