Court bans Florida compounder from all manufacturing until it can meet FDA requirements

A federal court issued a permanent injunction against a Florida sterile drug compounder, halting the company from manufacturing or distributing any products until it can comply with FDA rules and regulations.

The U.S. District for the Middle District of Florida issued the injunction against Premier Pharmacy Labs, a sterile compounding pharmacy that works with hospitals, surgery centers and physician clinics, and its owner, Vern A. Allen, according to the FDA.

The court took the action after years of conflict between the company and the regulatory agency. The issues started in 2014 when the agency issued a warning letter after finding unsanitary conditions at the company’s facility in Weeki Wachee, Florida. A follow-up inspection in 2016 resulted in a regulatory meeting with Premier in January 2018. That spring, the company recalled sterile injectables due to lack of sterility assurance.

Then, in April 2019, the agency conducted another inspection that resulted in a nationwide recall of almost two dozen unexpired drugs due to a lack of sterility assurance. In June that year, Premier halted all drug manufacturing at the facility.

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During its inspections, the FDA found problems with insufficient environmental controls, potential cross-contamination and lack of product-specific process validations. The complaint also cited Premier with manufacturing and distributing drugs not approved or exempt from approval because the products did not meet all statutory requirements for outsourcing.

“Premier Pharmacy and its owner placed patients at significant risk,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs.”