The following are a list of biological CBER compliance programs:

Biologics

7341.002: Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
7342.001: Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
7342.002: Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors
7342.007: Imported CBER-Regulated Products
7342.007 Addendum: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
7342.008: Inspection of Licensed In-Vitro Diagnostic (IVD) Devices
7345.848: Inspection of Biological Drug Products
Replaces 7342.006 – Inspection of Plasma Derivatives of Human Origin, 7345.001 – Inspection of Licensed Allergenic Products, 7345.002 – Inspection of Licensed Vaccines

Content current as of:

06/12/2025
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Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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