Lilly Receives FDA Warning Letter
Eli Lilly & Company 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.
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.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
