Compounder Receives Warning Letter Over Sterility, Labeling and Reporting Issues

A Mississippi compounder received an FDA warning over a multitude of GMP issues at one of its facilities.

An inspection conducted at Coastal Meds’ facility in Biloxi uncovered “serious deficiencies” in the company’s production of sterile drug products, leading to six citations.

One example was an inspector witnessing an employee’s clothing brush across the tops of open vials of drugs, potentially contaminating the contents. In a cleanroom, an inspector saw another employee produce sterile compounds without appropriate protective gear.