IHS Chemical Week

U.S. Regulators Warn Eli Lilly for Lapses at API Facility

9:49 AM MST | March 1, 2010 | Deepti Ramesh

The U.S. FDA has issued a warning letter to Eli Lilly’s active pharmaceutical ingredients (API) facility at Carolina, Puerto Rico, for a significant deviation from the current good manufacturing practice (cGMP). An FDA inspection of the facility last July identified a significant deviation from cGMP requirements for the manufacture of APIs, and the deviation causes Eli Lilly’s API lyspro insulin zinc crystals, used in Humalog for diabetes treatment, to be adulterated, FDA says. The response from Eli Lilly, which the FDA received last August, lacks...


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