The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
According to the warning letter from the US Food and Drug Administration (FDA), Lilly failed to adequately investigate critical deviations and the failure of a batch to meet its specifications or quality standards.
In a statement to in-PharmaTechnologist, Angela Sekston, vice president, external communications and corporate responsibility, said: “Lilly is committed to maintaining high quality standards in our manufacturing practices.
“As such, Lilly is taking prompt action to address the Agency’s concerns. We have assessed this matter and determined that there are no safety and efficacy implications for patients.”
The allegations focus on 24 batches of Lyspro Insulin Zinc Crystals, the active pharmaceutical ingredient (API) in Humalog, which were released between December 2007 and March 2008.
Lilly tested the product, as part of an investigation into 36 batches, but the FDA claims the method used was not validated for its intended use. The warning letter states that 24 of the 36 batches were released.
The FDA also flags up a similar event which occurred at a sister plant of the facility in Carolina, Puerto Rico. When the event was detected at the sister site Lilly rejected the material and performed extensive cleaning on the affected unit, according to the FDA.
Lilly responded to the FDA’s claims on August 21 2009. However, the agency believes the response fails to detail specific changes Lilly has made to cleaning procedures and visual appearance inspection.
Furthermore, the FDA states Lilly’s response is inadequate because it lacks an “evaluation to adequately demonstrate why 24 API released batches are suitable for their intended use”.
It is unclear from the heavily redacted letter what the API-related problems were.