FDA EIR - Baxter Healthcare Corporation - December 21, 2018

A directed For-Cause cGMP inspection was conducted at Baxter Healthcare Corporation's Jayuya, PR facility from December 3-21, 2018. This inspection served as a follow-up to a previous Official Action Indicated (OAI) inspection conducted in 2016, focusing on the manufacture of sterile injectable drug products. The review covered the Quality, Production, Facilities and Equipment, and Laboratory Control Systems, adhering to regulatory frameworks CP #7356.002A and #7356.021.

The inspection revealed a critical failure by Baxter to implement acceptable corrective actions from the prior OAI inspection. Notably, 8 of the 12 significant deficiencies cited in the current FDA-483 Inspectional Observations were repeat violations, some dating back to 2010. Key issues included profound failures within the Quality Unit, such as inadequate controls to ensure drug product efficacy and quality, insufficient evaluation and approval of Out-of-Specification (OOS) investigations, and a lack of timely monitoring for product stability and investigation closures.

Additional violations encompassed inadequate procedures for thoroughly reviewing unexplained discrepancies (including microbial out-of-limits), invalidating laboratory data without scientific justification, and an unestablished written stability program. Deficiencies in facilities and equipment included buildings not maintained in good repair (e.g., leaks, condensation) and equipment lacking proper maintenance and calibration. The company also lacked adequate written procedures for production and process controls, including detailed sampling and testing for components prone to defects like "Sleeve Stopper with Shrink Band Fall Off." In response, the Chief Quality Officer committed to providing a written response to the FDA within fifteen business days for evaluation.