Samsung Biologics Receives Form 483 From FDA Over South Korean Manufacturing Site

The FDA has issued Samsung Biologics with a Form 483 containing six key observations following site inspections on 21-25, 28-31 August and 1 September 2023.  A Form 483 is issued to companies at the conclusion of an FDA inspection if conditions may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.  A Form 483 does not constitute a final FDA determination of violation of the FD&C Act or any relevant regulations.  Fierce Pharma has reported that Samsung is taking the FDA’s concerns seriously and has “developed a comprehensive plan” to address the manufacturing shortfalls swiftly.