Micro Distributing II, Ltd. – FDA Warning Letter, Jul 16, 2010

The FDA issued a Warning Letter to Micro Distributing II, Ltd. following an inspection from July 13-16, 2010, and subsequent website review. The firm markets and distributes IVD rapid screening tests for drugs of abuse, including STATDIP, STATCASSETTE, STATCUP, STATCUPII (urine tests), and STATSWAB (oral fluid test).

The FDA determined these products are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. They are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. The firm did not respond to the Form FDA 483 inspectional observations.

While the manufacturer, (b)(4), has 510(k) clearance for some urine drug tests, Micro Distributing II, Ltd. promotes their urine tests for new, uncleared indications, such as testing for propoxyphene (PPX), buprenorphine (BUP), adulterants (pH, Oxidants, Specific Gravity), urine temperature, and up to 15 drugs. The STATSWAB oral fluid test has no 510(k) clearance or approval.

Despite labeling some products "For Forensic Use Only," the FDA found sales