US FDA warns Lilly over GMP violations on Humalog API production
This article was originally published in Scrip
The US FDA has issued a warning letter to Lilly citing a "significant deviation" from current good manufacturing practice at its API production facility in Carolina, Puerto Rico, which caused the firm's API, lyspro insulin zinc crystals, to be "adulterated within the meaning…of the FD&C Act". Batches were used in the production of the finished product Humalog (insulin lispro). A company said it had "assessed this matter and determined that there are no safety and efficacy implications for patients".
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