FDA 483 - Grifols Biologicals LLC - May 03, 2024

The FDA conducted an inspection of Grifols Biologicals LLC, a biologics and plasma derivatives manufacturer in Los Angeles, CA, from April 25 to May 3, 2024. This inspection resulted in a Form FDA 483, detailing observations of conditions that indicate non-compliance with regulatory standards for drug manufacturing. Key findings included significant deficiencies in the environmental monitoring system within aseptic processing areas, where the placement of monitoring equipment like air samplers and settle plates was deemed ineffective for high-risk activities such as filling and stoppering for IGIV product lines. Several of these environmental monitoring issues were repeat observations from previous inspections. Additionally, the firm failed to consistently follow its own complaint handling procedures for drug products, including Albutein®, by not using correct documentation forms or consistently recording complaint receipt dates for multiple quality complaints. The inspection also noted that facilities used for manufacturing drug substances were not maintained in a state of good repair, with observations of rust, iron oxide, separating silicone, and holes in wall panels within a Grade C manufacturing room. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, highlight practices that could affect product quality and safety, requiring Grifols Biologicals LLC to implement comprehensive corrective actions to address these findings and ensure compliance with Good Manufacturing Practices.