FDA Cites Repeat Offender Over Sterility, GMPs

Ongoing quality issues at an Oklahoma outsourcing facility drew the ire of the FDA and a Form 483 for Qualgen—not a first for the company.

Seven different drug lots failed sterility testing, in part due to air quality problems at the Qualgen facility that the FDA has flagged at the company for years.

In the agency’s most recent inspection, conducted from April 17 through May 10, inspectors found continued air quality problems, including HEPA filters that were not properly sealed, allowing unfiltered air to enter cleanrooms.

This 483 is not the first time the FDA has cited Qualgen for deficiencies or GMP violations. An inspection between August and September of 2015 noted that ceiling tiles in the facility’s ISO 7 cleanrooms were not fully sealed, allowing unfiltered air to enter. In October 2015, the FDA recommended the company recall all non-expired drug products intended to be sterile, which Qualgen did voluntarily.