A Valeant Pharma Unit Has Problems Making Drugs

A Valeant Pharma Unit Has Problems Making Drugs

July 27th, 2011 // 12:38 pm @ jmpickett

Valeant Pharmaceuticals has been on an acquisition spree, but perhaps the Canadian drugmaker may want to conduct a bit more due diligence before its next purchase. One of its recent deals was for Sanitas, which is based in Lithuania and controls Jelfa, another drugmaker based in Poland and that actually produces much of the Sanitas portfolio . Valeant is paying about $455 million in cash .

However, a July 14 warning letter issued by the FDA to Jelfa notes that the Polish drugmaker has some basic problems with quality control. During an October 2010 inspection, the FDA found Jelfa did not thoroughly investigate the failure of a batch or any of its components to meet specifications, which the agency called an unacceptable practice. The FDA then offered a tutorial after Jelfa failed to investigate its manufacturing process and facility controls to identify the cause of a sterility failure.

“This information from the failure investigation also helps determine how many additional other batches may be affected,” the agency wrote Jelfa president Marek Wojcikowski in summarizing its October 2010 inspection, during which various violations of good manufacturing practice were cited. “Please note that when microbial growth is observed, a lot should be considered nonsterile and an investigation conducted.”

In case Wojcikowski missed the point, the FDA was specific: “For information on sterility testing, see Section XI of the FDA’s Guidance on Sterile Drug Products Produced by Aseptic Processing.”

There were other problems. Employees were seen following poor aseptic techniques; tubing ends used to connect solution tanks to a filling line were not protected prior to sterilization to reduce the potential of contamination, and disinfectant efficacy studies were not completed for a few disinfectants used to sanitize surfaces in the sterility testing suite and production aseptic core filling line. One more problem: inadequate vendor qualification of active pharmaceutical ingredient, or API, suppliers.

“Repeat citations from prior inspections indicate that your quality control unit is not exercising its responsibilities, and may not have the appropriate authority to carry out its responsibilities. Due to continuing CGMP issues at your firm, we recommend you engage a third party consultant having appropriate CGMP expertise to assess your firm’s facility, procedures, processes, and systems to ensure that your drug products consistently meet standards for identity, strength, quality, and purity,” the FDA concludes.

This is not the first time that Jelfa reportedly had production problems. In 2006, the Polish government ordered the drugmaker to halt production after mislabeled meds were placed on the market. Jelfa reportedly distributed vials labeled for a drug used to treat allergies and inflammation, but actually contained a drug for treating muscle paralysis during emergency surgery . This occurred just a few months before Sanitas bought Jelfa.

We asked Valeant for a reply and will update you accordingly. UPDATE: A Valeant spokeswoman wrote us this: “We do not yet own Sanitas as the deal has not yet closed, so cannot really comment on their business at this time. As part of the due diligence process, we did verify that Sanitas does have appropriate certifications in Poland and any US exposure is extremely small, if anything.”

Source: Pharmalot