Sterile Compounding Processes Corrected at Qualgen

Qualgen has taken corrective actions concerning its compounding facility conditions and sterility processes.

In response to an FDA warning about its sterile products, Qualgen LLC has taken corrective actions concerning its compounding facility conditions and sterility processes.

In October, the FDA alerted health care professionals and patients that investigators observed unsanitary conditions and poor sterile production practices at Qualgen’s facilities in Edmond, Oklahoma. Based on these findings, the FDA recommended that Qualgen cease all sterile compounding operations until it corrected these problems.

Qualgen general manager Shaun Riney stated the company started making corrections “as soon as we became aware of what the FDA was observing during its September audit,” even before the agency issued its warning to health care professionals in October.

Although the FDA reported that Qualgen did not stop its sterile compounding operations, the company did comply with the agency’s recommendation to voluntarily recall 67 lots of non-expired drugs compounded before September 1, 2015, “even though [the products] had already been tested and proven sterile,” Riney said.

According to Riney, no adverse events have been reported in relation to Qualgen’s products, which encompass a wide range of compounded estradiol and testosterone pellets.

He maintained that the company has “done everything to be in compliance with the FDA’s recommendations.”

Qualgen pharmacist Peggy Ray stated that this experience “helped us improve our overall processes and heighten our awareness of everything we do.”

“This situation has not only improved our sterility processes in the lab, but it has allowed us to more reliably document the safety and efficacy of our products, ensuring the highest quality and safety for our providers and their patients,” Raley added in a statement.

Qualgen is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act.