Edmond-Based Drug Company Responds To FDA Requests

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Nov 30, 2015, 11:52 ET

EDMOND, Okla., Nov. 30, 2015 /PRNewswire/ -- Qualgen, a bio-identical hormone replacement pellet production company based in Edmond, Okla., has responded to recommendations made by the Food and Drug Administration (FDA) by performing all corrective actions concerning product recalls, facility conditions and validation of its sterility processes.

In October, the FDA recommended that Qualgen cease sterile operations until appropriate corrective actions have been implemented by the facility, and recall all non-expired drugs.

Qualgen lab technician Tim Taylor (left) and microbiologist John McManus sterilize testosterone pellets in its Edmond, OK-based bio-identical hormone replacement pellet production company. Qualgen recently responded to an FDA request to recall product and cease operations by performing all recommended corrective actions to ensure the sterility of its products.

Qualgen, an Edmond, OK-based bio-identical hormone replacement pellet production company, recently responded to an FDA request to recall product and cease operations by performing all recommended corrective actions to ensure the sterility of its products.

"Qualgen's overall goal has been, and always will be, to provide the safest, most effective sterile products to its customers," said Shaun Riney, general manager of Qualgen. "As soon as we became aware of what the FDA was observing during its September audit, we immediately began correcting the issues."

According to Riney, the fact that Qualgen began making corrections before the FDA formally published its recommendations in October has been a source of confusion to the public and for its clients. There have not been any reports of adverse reactions associated with the use of Qualgen products.

"In order to clear up any confusion, we want to make sure our clients, and especially the public, know that we have done everything to be in compliance with the FDA's recommendations," said Riney. "And, in addition to quickly making all necessary corrections, we have also voluntarily recalled the product that was in question, even though it had already been tested and proven sterile."

John McManus, a microbiologist for Qualgen, was hired very recently to oversee the Qualgen labs and all of its testing and processes.

"Because I have nearly 30 years experience in medical research, Qualgen has brought me in to ensure the integrity of our products from a sterility standpoint," said McManus. "I hold our staff to its highest capabilities and insist we follow best practices at all times in cleanliness, productivity and testing."

Qualgen's pharmacist, Peggy Ray, said this has actually been a learning experience for the company and staff.

"I'm really proud of our team and how we have pulled together," said Ray. "This experience has helped us improve our overall processes and heighten our awareness of everything we do."

Riney said that despite this minor setback, he expects the company to do nothing but thrive in the future.

"We respect the FDA and appreciate its input in helping us improve our products," said Riney. "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."

About Qualgen

Qualgen is a sterile compounding company based in Edmond, Oklahoma, that offers a wide range of compounded Estradiol and Testosterone pellets. Qualgen's mission is to develop and provide high quality formulations and exceptional customer service to healthcare practitioners and their patients. Qualgen is a FDA registered drug manufacturer with state of the art sterile labs that meet FDA current good manufacturing practice (cGMP) requirements.

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SOURCE Qualgen