Integra LifeSciences, which manufacturers medical devices used in surgery, has been fighting a mold problem at its collagen manufacturing facility in Plainsboro, NJ, for more than two years, the FDA reports.
In an SEC filing, the company ($IART) emphasized remediation efforts are on track. Furthermore, the FDA has not asked it to recall any products, and all of its clean rooms were in production at the end of the year. But as of Dec. 21, when a warning letter was sent to then-CEO Stuart Essig, mold was still being found throughout the plant despite efforts by an environmental contractor to address the problem.
The letter, which was posted Tuesday by the FDA, says mold was first found June 15, 2009, in the equipment storage area and a closet housing the company's deionized ultra-filtered water system that is directly adjacent to the ISO Class 7 Clean area. Mold was also visible in a room housing a water injection system. Samplings in 2009 found "mold types Aspergillus/Penicillium-like, Ascospores, Basidiospores, Stachybotrys, Ulocladiumanical and other/unidentified."
The company ties the cause to a leaky roof, which is being replaced, and high humidity, which is being addressed. Integra has told the FDA that despite the mold problems, risk analysis for products manufactured in the "Medical Manufacturing Area and the Integra Suite," the site of the final manufacturing steps of the Integra artificial skin products, showed they were suitable for manufacturing. However, the company shut down the Integra Suite for remediation and renovation in July.
The letter also criticizes Integra's cleaning validation procedures, and said validation for "Integra Artificial Skin Manufacturing Area Mixing tanks was not adequately completed."
In a January release, Integra says it "has provided detailed responses to the FDA as to its corrective actions on a monthly basis, remains on track with its actions and is aggressively working to address all of the issues that the FDA identified."