FDA 483 - Catalent Pharma Solutions, LLC - July 21, 2023

Catalent Pharma Solutions, LLC, a dietary supplement manufacturer in Saint Petersburg, FL, received an FDA Form 483 for multiple significant deficiencies observed during an inspection. The firm failed to establish adequate specifications for components, finished products, and labels, and exhibited issues with master manufacturing records, batch production records, and equipment sanitation. These findings indicate a lack of control over critical aspects of dietary supplement manufacturing.