What happens when a U.S. pharma company markets a product that is seriously contaminated and causes illness and death? Among other things, FDA investigates. What happens when the company’s senior management fails to make changes promised to the agency to prevent those outcomes from recurring and more illnesses and deaths result? And what happens to senior company management who misrepresent the company’s actions to the agency?

[Related: Click here to access a free report containing four GMP compliance case studies from author Jerry Chapman.]

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At the 2022 PDA/FDA Joint Regulatory Conference in mid-September, FDA CDER Office of Compliance Director Donald Ashley told a tale of those events happening, and the legal action his agency took against the company involved.

The case involves, “frankly, one of the most egregious violations that I have seen during my nearly six years as director of CDER Compliance,” Ashley stressed.

The story begins in 2016. The CDC and FDA were investigating a multistate Burkholderia cepacia outbreak that included more than 60 confirmed cases across 12 states. Several deaths were associated with the outbreak. B. cepacia is a gram-negative bacterium that is usually not harmful to healthy adults but can lead to respiratory and other infections in people with weak immune systems, chronic lung disease, and other conditions.

Testing by FDA and CDC confirmed that the infections were linked to contaminated product made by Florida-based PharmaTech, LLC. An FDA inspection of the company’s manufacturing facility identified B. cepacia in more than ten lots of the firm’s oral liquid docusate sodium product, known as Diocto Liquid. The inspection also detected B. cepacia in the water system used to manufacture the product.

For the inspection history of PharmaTech, LLC, including related documents, click here to access the site profile in Redica Systems. If you do not have access to Redica Systems, contact us to learn more about our site and organization profiles.

In response to the inspection findings, PharmaTech CEO Raidel Figueroa advised FDA that PharmaTech had ceased production and was going to re-engineer the purified water system to prevent future contamination.

“And this is where the situation really went from bad to much, much worse,” Ashley lamented. In March 2017, FDA learned that PharmaTech had re-started production.

The agency conducted a reinspection that month. During the inspection, “Figueroa repeatedly lied to the FDA,” Ashley asserted. “For example, he lied by excluding his docusate sodium product from the list that was provided to the FDA when we asked him to disclose all the products that the firm had resumed manufacturing. The firm had actually shipped 7,000 units of that product earlier that month.

“They also lied by falsely saying to FDA that PharmaTech’s new water system had met acceptance criteria, which was not true,” the CDER compliance director stated.

About three or four months later, in July 2017, the CDC notified FDA of a second round of multiple B. cepacia infections in pediatric patients at Stanford Children’s Health and Lucile Packard Children’s Hospital in Palo Alto, Calif., and Johns Hopkins Children’s Center in Baltimore, Md.

FDA investigated, collecting bottles of Diocto Liquid from those medical centers. Several of the bottles contained unacceptable amounts of bacteria, yeast, and mold, according to FDA lab testing.  Some bottles tested positive for B. cepacia. The FDA and CDC traced the product back to PharmaTech–product that was distributed in March of 2017. More deaths were associated with the second outbreak.

“In this instance, PharmaTech even refused to recall the product,” Ashled reported. “We had to work directly with the downstream distributors of the product to effect a recall to get it all off of the market.”

The agency immediately referred the case to its Office of Criminal Investigations.

In June 2022, Figueroa pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA, and distributing adulterated drugs. In August 2022, he was sentenced to 37 months in prison. Parents of victims that died during the B. cepacia outbreaks testified at the sentencing hearing.

Ashley characterized the case as “egregious, obviously for a number of factors, including total disregard for patient safety by senior company management, total disregard for quality, false statements made to the FDA during the inspection, of course, and the absolutely tragic consequences that resulted.”

Additional Resources

Why am I Being Inspected Again So Soon After a Pre-Approval Inspection?
Who Decides if my FDA Inspection is Classified OAI?
Where is My EIR?
FDA on Compliance Issues in Pharma

4 GMP Case Studies

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