FDA Issues Warning Letter After Inspection
Lilly Working With FDA to Quickly Resolve Issues
Eli Lilly and Company (NYSE:LLY) announced today that it is working diligently to address issues raised as a result of a U.S. food and Drug Administration inspection of its injectable product manufacturing facility in Indianapolis. The inspection cited Current Good Manufacturing Practice deficiencies in areas such as quality control, certain validation practices and other procedures.
"We are working in conjunction with the FDA - and with a keen sense of urgency - to resolve all issues raised as a result of the FDA inspection," said Scott Canute, vice president of manufacturing at Lilly. "We are confident we can correct all issues and believe that the timing of our new product launches will not be affected. Further, these corrections will not disrupt our ability to supply existing products. We remain confident of the safety and effectiveness of all products manufactured in this facility."
Lilly does not anticipate any material financial impact as a result of these manufacturing changes and therefore is not changing its previously announced earnings guidance.
On March 6, Lilly received a warning letter from the FDA following a routine inspection by the agency in February 2001 in connection with the company's application for approval of the rapid-acting intramuscular formulation of Zyprexa® (olanzapine). Lilly has action plans in place to address the FDA's observations. The company is working closely with the FDA and expects to be ready for reinspection within the next two months.
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