FDA WARNING_LETTER - Medical Supply Liquidators Llc - June 19, 2014

On June 10-19, 2014, FDA investigators inspected Medical Supply Liquidators LLC, identifying violations related to unapproved new drugs and misbranded/adulterated medical devices. The firm distributed unapproved new drugs, including Vitamin B12 Cyanocobalamin and Methylcobalamin injections, violating sections 301(d) and 505(a) of the Act, as no FDA-approved applications were on file. These drugs were also misbranded under section 502(f)(1) because they lacked adequate directions for lay use and were not exempt from this requirement.

The firm also sold the Oasis (MVI) 3 cc Luer Lock syringe without clearance or approval, making it adulterated under section 501(f)(1)(B) and misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution. Additionally, the firm marketed prescription-only devices (e.g., Dual Channel Tens-7000 5 mode, various needles and syringes) to end-users without a prescription, causing them to be misbranded under section 502(f)(1) due to inadequate directions for use. Iowa state law violations for distributing prescription-only devices and drugs without proper licenses were also noted.

The FDA requires immediate discontinuation of all unapproved drug distribution and cessation of activities resulting in mis