Failings at Lilly Humalog plant catch FDA’s eye
pharmafile | February 26, 2010 | News story | Manufacturing and Production | Humalog, lilly
Eli Lilly has been sent a warning letter about a production facility in Puerto Rico, which says the company failed to adequately investigate problems with manufacturing the active pharmaceutical ingredient (API) used to make an insulin-based drug for diabetes.
The letter from the US Food and Drug Administration (FDA) – available to read here – concerns a facility in Carolina which makes lyspro insulin zinc crystals, the API used in Lilly’s Humalog product.
The main issue identified by the agency was that Lilly failed to investigate “critical deviations or a failure of a batch to meet its specifications or quality standards”.
Specific deficiencies in Good Manufacturing Practice (GMP) at the plant included the use of an unvalidated test method to investigate the quality of 36 batches of the API, 24 of which were subsequently released and used to make finished Humalog.
The use of the test and other related factors could have led to manufacturing of Humalog that was subpotent and with an altered physical appearance, according to the FDA latter.
It also notes that Lilly was aware of a similar case at another of its facilities in which the material had been rejected and the equipment used to make the batches cleaned.
The deviations from GMP were identified during an FDA inspection of the facility in July 2009, and Lilly responded to the points raised by the agency the following August, including measures relating to enhanced cleaning procedures and more rigorous visual inspection of materials.
The FDA said however the company’s response “lacked sufficient corrective actions”.
Humalog is one of Lilly’s biggest selling products, bringing in a little under $2 billion worldwide in 2009 and accounting for 9% of total company revenues. The product is also among Lilly’s fastest-growing lines, advancing 13% year-on-year.
Related Content
Lilly’s COVID-19 drug has EUA revoked in favour of combination therapy
The FDA have revoked Emergency Use Authorization (EUA) of Eli Lilly’s bamlanivimab drug for the …
Lilly’s ulcerative colitis treatment meets all key endpoints in Phase III trial
Eli Lilly’s mirikizumab treatment for ulcerative colitis (UC) patients has met the primary endpoints and …
University of Glasgow and Lilly sign £4.6m immunological disease partnership
The University of Glasgow and Eli Lilly and Company have entered into a research collaboration, …
