The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers.
The agency investigators found that the firm did not use enough smoke in its studies to properly assess air disturbances and turbulence. Operators also failed to wear gloves or cleaning room garments during the studies.
The firm did not qualify service contract service providers used for various tasks, including analyses, biological indicator evaluations, disinfectant efficacy studies, and eye examinations for employees. It also failed to requalify its contract testing lab.