Biologics Manufacturer Warning Letters

Biologics Manufacturer Warning Letters

Biological products—such as vaccines, blood and blood components, gene therapies, and cellular therapies—are some of the most complex and sensitive therapies regulated by the FDA. To protect public health, the FDA issues Warning Letters when biologics manufacturers violate regulatory requirements, such as current Good Manufacturing Practices (cGMP), improper labeling, unapproved marketing claims, or failure to ensure product sterility and safety.

This page features the most recent FDA Warning Letters issued to biologics manufacturers. These letters serve as critical enforcement tools and offer valuable insights into common compliance pitfalls across the biologics industry. Whether you’re a regulatory professional, quality manager, or simply concerned with public safety, these letters highlight where and how companies fall short—and what steps must be taken to correct deficiencies and regain compliance.

Stay informed. Learn from real-world examples. And use these insights to strengthen your own quality and regulatory practices.

The following warning letters were issued by FDA’s Center for Biologics Evaluation and Research (CBER).