FDA EIR - Lilly del Caribe, Inc - February 25, 2022

An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, was conducted from February 9 to February 25, 2022. This abbreviated inspection, focusing on Quality and Laboratory Controls systems under the drug manufacturing compliance program (CP 7356.002), identified two significant objectionable conditions, leading to the issuance of a 2-item Form FDA-483.

First, the company's laboratory investigations into out-of-specification (OOS) results for oral solid drug products, including Abemaciclib and Lasmiditan, were deemed inadequate. Root causes were frequently unconfirmed or lacked scientific support, and investigations often failed to assess the impact on other concurrently analyzed batches. OOS results were improperly invalidated, and new sample preparations were reported without sufficient justification, a practice contrary to 21 CFR 211.192.

Second, the quality control laboratory's procedures permitted the modification of parameters in the Empower system to recalculate test results. This occurred when samples, such as those for Olumiant and Cialis, were prepared using incorrect glassware. Instead of re-testing, dilution factors were altered to bring results within specifications, indicating a deficiency in scientifically sound laboratory controls, in violation of 21 CFR 211.160(b).

Lilly del Caribe's management was informed of potential legal sanctions and committed to providing a written response detailing corrective actions within 15 working days.