In Bloomberg BNA Article, Howard Sklamberg Discusses Modernization of FDA Form 483
Bloomberg BNA’s Pharmaceutical Law & Industry Report has published the article “Reforming the 483: FDA’s Modernization of Its Process for Documenting Inspection Results,” written by Akin Gump health partner Howard Sklamberg. The article examines the use of form FDA 483 by Food and Drug Administration investigators to document potential violations of the Federal Food, Drug and Cosmetic Act.
Sklamberg writes about some of the problems he sees with FDA 483. He also discusses the 483 process, including the consequences of receiving such a form.
Concluding, Sklamberg says stakeholders should engage with the FDA as it considers new approaches to documenting investigators’ observations. He writes that they “should press for a process that is consistent with the powerful effect of inspection reports and with FDA’s efforts to promote public health by modernizing its approach to inspections.”
To read the full article, please click here.