Qualgen Responds to FDA Recommendations

The FDA recently ordered the company to cease all sterile operations.

Qualgen, a bio-identical hormone replacement pellet production company based in Edmond, Okla., has made all corrective actions concerning product recalls, facility conditions and validation of its sterility processes brought to their attention by the FDA, according to a company press release.

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'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."

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."

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