FDA 483 - Laboratorios Grifols, S.A. - July 26, 2024

Laboratorios Grifols, S.A. in Parets Del Valles, Spain, a drug manufacturing facility, was cited for four observations during an FDA inspection from July 22-26, 2024. The observations primarily concern deficiencies in written procedures for production and process controls, incomplete batch and laboratory records, and inadequate cleaning and maintenance procedures. These issues indicate a lack of robust control over critical manufacturing and testing processes.