| FDA unable to trace source of ReNu infection cases |
| Tuesday, 16 May 2006 | |
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The Food and Drug Administration says that it has been unable to locate the source of an infection outbreak among contact lens users during its inspection of Bausch & Lomb’s Greenville, South Carolina plant. According to a preliminary statement concerning the inspections, the agency plans to conduct further testing in the hopes of locating the infection source. During its investigation, the FDA says that it tested “environmental factors, raw materials, in-line manufacturing processes and finished product” at the plant but did not find any correlation between these and the outbreak of Fusarium keratitis symptoms. Bausch & Lomb has proposed that certain qualities of MoistureLoc’s formulation may be responsible for the Fusarium outbreak. But the FDA has been unable to find conclusive evidence to support this theory. The FDA statement also says that its findings were only preliminary and that it would release a complete report when its investigations have concluded. However, the agency added that its findings suggest that Bausch & Lomb may have deviated from “current good manufacturing practice” at the Greenville plant while producing ReNu with MoistureLoc. |