FDA letter vetoes Lilly API test

Eli Lilly is the recent recipient of an FDA warning letter concerning adulterated API at a manufacturing facility in Puerto Rico. In the letter, the regulator charges that the drug giant shipped 24 of 36 batches of substandard Lyspro Insulin Zinc Crystals, based on results from tests not validated for that purpose.

The letter also states that the company knew of a similar case of adulteration (details of which are removed from the Internet version of the letter) at another of its facilities, and that the manufacturing team at that facility rejected the material and then cleaned the equipment involved. The API is used in the diabetes drug Humalog.

Eli Lilly responded to the FDA in late August, following the inspection last July. In its response, the drugmaker promised to stop using the unapproved test as an indicator of continued processing. It also promised to enhance its cleaning activities related to the event and to improve its visual inspection techniques.

But the promise was not enough, as has been the case recently with the regulator. The FDA requested additional details on the changes to both the cleaning and inspection procedures. The FDA also found the response lacking because it failed to demonstrate why the 24 released batches were suitable for use.

- see the warning letter