Two Compounders Hit for Quality Control Issues

The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations.

A March inspection of Meditech Laboratories’ Las Vegas-facility uncovered a slew of deficiencies related to the facility’s testing of sterile drugs and aseptic processing, according to the Form 483.

Specifically, the facility released products without validating either their potency or sterility tests and without needed approval from the firm’s quality control unit. The firm also neglected to perform tests on the containers to ensure adequate protection against contamination in refrigerated storage.