Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry
This article was originally published in The Tan Sheet
Executive Summary
FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency
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FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency. "The inspection found many serious deviations, some of which involved data manipulation and inadequate testing procedures," FDA says in an Aug. 28 warning letter to Leiner. The warning letter could delay the firm's planned reentry into the U.S. OTC market. Leiner has removed OTC drug and nutritional product manufacturing operations from its Fort Mill, S.C., facility and plans to conduct manufacturing at its Garden Grove, Calif., and Wilson, N.C., offices and packaging at its Carson, Calif., headquarters 1 (Also see "Leiner Asks FDA About Restarting U.S. OTC Operations, Posts $27.5 Mil. Loss" - Pink Sheet, 20 Aug, 2007.), p. 5). Additionally, Leiner has said it plans to conduct its eastern U.S. packaging and distribution operations at the South Carolina facility. However, in the warning letter FDA officials tell Leiner their inspections indicate packaging should not be done at the Fort Mill facility in part because of the "failure of your Quality Control Unit to fulfill its responsibilities." "Because of the poor [good manufacturing practice] controls in the areas inspected ... we have not assurance that your packaging operations will be properly controlled," according to officials in FDA's Atlanta District Office. The warning letter acknowledges the firm's corrective action plans, but notes inspectors found "many serious deviations" including "data manipulation and inadequate testing procedures." Products manufactured at the Fort Mill facility "under these violative conditions put consumers at significant risk," the agency says. The firm deviated from GMPs for OTC products by not performing "appropriate stability testing using reliable, meaningful and specific test methods in determining appropriate storage conditions and expiration dates" and not having an adequate quality control unit and supporting lab facilities and for not setting up a stability testing program, FDA says. Additionally, the firm did not establish an adequate controls and procedures mechanism to "assure the authenticity, integrity and security of all electronic records including data generated in the laboratory, components, in-process materials, drug products, and all procedures or specifications impacting on the identity, strength, quality and purity" of its products as required by law. Product issues such as broken tablets and incomplete coating were not investigated in accordance with standard operating procedures in the firm's "Non Comformance Report," investigators pointed out. "During the last two years, over 100 lots of various products had to be screened for broken tablets, sticking, black specks, coating defects, and/or screened for potential metal contamination," the warning letter said. Meanwhile, Department of Justice investigators have launched a probe into the production, control and distribution of OTC products at the facility, the company announced in a Sept. 11 regulatory filing. A DOJ official declined to provide specific details on the investigation. During a Sept. 18 conference call in which no questions were taken, Leiner CEO Robert Kaminski reiterated the firm's contention that quality control issues were caused by the conduct of Fort Mill employees, including some who have been dismissed. "The company believes that there were certain quality control people in Fort Mill who appear to have been operating outside of our core values and operating principles," Kaminski said. Leiner voluntarily shut down its U.S. OTC operations and recalled some products after FDA officials found the discrepancies when they inspected the Fort Mill facility on multiple occasions this year (2 (Also see "Leiner’s U.S. OTC Operations Face Regulatory, Competitive Obstacles" - Pink Sheet, 18 Jun, 2007.), p. 4). Leiner will provide further details on the investigations during its fiscal 2008 second-quarter earnings call, set for November. - Robert W. Mitchell ([email protected]) |