Biologics Manufacturer Warning Letters
FDA warnings to the biologics industryBiologics 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).
Biologics Warning Letters
|
Posted Date |
Letter Issue Date |
Company Name |
Subject |
|
07/22/2025 |
07/07/2025 |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
|
|
07/01/2025 |
06/13/2025 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
06/03/2025 |
03/25/2025 |
Bioresearch Monitoring Program |
|
|
05/20/2025 |
05/05/2025 |
Unapproved New Drugs/Misbranded |
|
|
05/20/2025 |
12/16/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
03/18/2025 |
03/10/2025 |
CGMP/Deviations/Biologics License Application (BLA) |
|
|
02/25/2025 |
02/14/2025 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
02/04/2025 |
01/17/2025 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
01/28/2025 |
12/30/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
01/28/2025 |
01/17/2025 |
CGMP/Deviations/Biologics License Application (BLA) |
|
|
01/21/2025 |
12/12/2024 |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
|
|
01/07/2025 |
12/12/2024 |
Unapproved New Drugs/Adulterated |
|
|
11/19/2024 |
11/01/2024 |
Unapproved New Drug/Unlicensed Biological Product Violations |
|
|
10/22/2024 |
10/11/2024 |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
|
|
10/22/2024 |
10/01/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
10/22/2024 |
10/01/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
10/22/2024 |
10/10/2024 |
Clinical Investigator |
|
|
10/15/2024 |
10/08/2024 |
CGMP/Blood & Blood Components/Adulterated |
|
|
09/06/2024 |
08/16/2024 |
CGMP/Finished Pharmaceuticals/Adulterated |
|
|
09/03/2024 |
08/20/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
08/27/2024 |
06/28/2024 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
08/27/2024 |
07/26/2024 |
CGMP/Finished Pharmaceuticals/Adulterated |
|
|
08/13/2024 |
05/29/2024 |
Bioresearch Monitoring Program/IRB |
|
|
07/16/2024 |
06/21/2024 |
Bioresearch Monitoring Program/IRB |
|
|
03/12/2024 |
02/09/2024 |
CGMP/Deviations/Biologics License Application (BLA) |
|
|
02/13/2024 |
01/31/2024 |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
|
|
01/09/2024 |
12/20/2023 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
10/25/2023 |
10/24/2023 |
Dietary Supplement/Adulterated |
|
|
09/29/2023 |
09/28/2023 |
Unapproved New Drugs/Misbranded |
|
|
08/09/2022 |
08/03/2022 |
Bioresearch Monitoring Program |
|
|
02/22/2022 |
02/10/2022 |
Good Laboratory Practice (GLP) |
|
|
07/06/2021 |
06/25/2021 |
Unapproved and Misbranded Product Related to Influenza Virus |
|
|
11/20/2020 |
11/18/2020 |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
|
|
08/25/2020 |
08/12/2020 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
|
|
08/19/2020 |
08/17/2020 |
PA Green Wellness LLC dba A Predictive Biotech Certified Facility |
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
|
08/19/2020 |
08/17/2020 |
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
|
|
07/23/2020 |
07/21/2020 |
21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
|
05/22/2020 |
05/21/2020 |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
|
|
03/18/2020 |
03/16/2020 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |