FDA temporarily shutters ‘filthy’ compounding pharmacy

FDA recently announced it had closed the operations of a major Florida compounder due to drugs that contained “filthy, putrid, or decomposed substances.” Several years ago, drugs compounded by Franck’s Compounding Lab caused eye infections that led to vision loss.

FDA, via the U.S. Department of Justice, has prohibited Paul W. Franck of Ocala, Florida, from manufacturing and distributing compounded drugs until he complies with the FD&C Act and its regulations.

Courtesy: Shutterstock/Muellek JosefFranck owned and operated numerous compounding pharmacies over the past 20 years, including Franck’s Lab Inc., doing business as Franck’s Compounding Lab, and Franck’s Lab Inc., doing business as Trinity Care Solutions.

FDA said Franck manufactured drugs that were considered adulterated under the FD&C Act because they contained filthy, putrid, or decomposed substances; were prepared, packed, or held under insanitary conditions; and fell below the quality and/or purity standards they purported to possess.

“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Today’s action reflects the FDA’s continued efforts to take appropriate and aggressive enforcement action against those who put patients’ health at risk by choosing not to follow the law.”

In 2014, Trinity Care Solutions recalled all sterile drugs and ceased compounding operations after a FDA inspection revealed violations that could compromise drug sterility.

“These violations included the presence of dead spiders, beetles, ants, wasps, and cockroaches in the ceiling panel directly above the area where employees prepare for sterile processing; lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction into the clean room; and failure to adequately clean and sanitize sterile compounding areas,” FDA said in a statement.  

In 2012, contaminated ophthalmic drugs compounded by Franck’s Compounding Lab were linked to at least 47 cases of eye infections, including at least 39 cases of temporary or permanent vision loss.

The company subsequently recalled all sterile products and ceased operations. The company also received a warning letter from the agency.

In addition, in 2009, FDA said 21 polo ponies died after receiving a drug product compounded by Franck’s Compounding Lab that contained 100 times the amount of selenium that should have been administered.