Articles

John Carney, Lee Rosebush, Susrut Carpenter, Andrew Serrao Author Article about FDA Pharma Facility Inspections Amid Pandemic

Articles / April 22, 2020

An article authored by Partners John Carney and Lee Rosebush, Counsel Susrut Carpenter, and Associate Andrew Serrao was published on April 22, 2020, by Contract Pharma. The article, “FDA cGMP Inspections Amid COVID-19 Pandemic,” cautions that, despite the Food and Drug Administration’s postponement of most facility inspections, the global pharmaceutical industry should be prepared for heightened scrutiny as the COVID-19 crisis develops.

The authors note that the FDA is likely to focus on a facility’s sanitary conditions and the health and hygiene of employees. They advise that companies be committed to bringing processes into compliance before an FDA inspection and be prepared to respond rapidly to any issue or violation revealed in an inspection.

Read the article.