Lilly Receives FDA Warning Letter

On February 5, 2010, Eli Lilly & Company (Indianapolis, IN) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico. The APIs, lyspro insulin zinc crystals, are used for the production of Humalog, the company’s fast acting insulin analog, for treating type 1 diabetes in adults.

The letter describes significant cGMP deviations identified during an FDA inspection that was conducted at the company’s API manufacturing facility located at Carolina, Puerto Rico, between July 8 and 31, 2009.

The key deviation cited was that the company failed to adequately investigate critical deviations in 36 batches of API, 24 of which were released for further processing. Furthermore, the company was aware that a similar event at a sister plant had led to that facility’s rejection of the API and extensive cleaning operations. Also, despite the results of studies showing a lack of linearity in the test method, the company failed to assess all affected batches of the APIs that were released for further processing.

Other deviations cited in the warning letter were related to incomplete investigations of stability and potency for these lots and failures to validate changes in cleaning procedures. The letter said the company’s response, on August 21, 2009, did not sufficiently address these concerns. Under the FDA’s new rules put in place last year, the company has 15 days to respond to the warning letter.

FDA warning letter