Puerto Rican Facility Cited for Manufacturing and Quality Issues
An Eli Lilly facility in Puerto Rico drew the FDA’s attention for manufacturing and quality deficiencies related to its breast cancer treatment abemaciclib.
An agency inspection of the Lilly del Caribe facility found the quality unit misclassified several manufacturing deviations as “observations” and failed to carry out adequate investigations and corrective actions for nonconformances during the manufacturing and testing of abemaciclib tablets, the Form 483 said.
The deviations related to tablet weight and thickness checks after process interruptions, the coating process, and out-of-limits values.
The investigators also noted inadequate maintenance and validation for the near infrared (NIR) spectroscopy equipment.