Vaccines, Blood & Biologics
Resources for You
- Types of Regulatory Action Letters that may be Issued by CBER
Compliance Programs (CBER) Recently Issued Guidance Documents
- CMC and GMP Guidances (Searchable by Publication Year)
- Adverse Events and Product Deviation Guidances (Searchable by Publication Year)
- Exporting CBER-Regulated Products
Importing CBER-Regulated Products into the United States
Office of Compliance and Biologics Quality (OCBQ)
CBER's Office of Compliance and Biologics Quality (OCBQ ) has many responsibilities, including the following:
Inspection, Surveillance, and Compliance Activities
- Ensures the quality of products regulated by CBER over their entire lifecycle through pre-market review and inspection, and post-market review, surveillance, inspection, outreach, and compliance.
- Monitors the quality of marketed biological products through surveillance, inspections, and compliance programs; reviews, evaluates and takes appropriate compliance action, in coordination with other Agency components.
- Reviews and evaluates all administrative action recommendations including suspension, revocation, denial of license, disqualification of investigators, and recommended civil and criminal actions, including seizures, injunctions, and prosecution based on findings of inspections and investigations.
- Directs the biologic product shortages program for CBER-regulated products.
- Directs the recall program for CBER-regulated products.
- Directs CBER's bioresearch monitoring program, and takes appropriate compliance actions, in coordination with other Agency components.
Biological Product Deviation Reports (BPDRs) and Blood Collection and Transfusion Related Fatality Reports
- Directs CBER's program for Biological Product Deviations Reports (BPDRs) and reports of complications of blood collection and transfusion that are confirmed to be fatal.
Pre- and Post-Market Approval Activities
- Reviews, evaluates, and takes appropriate action on manufacturing supplements submitted by manufacturers (except blood and plasma establishments), and leads pre-approval and pre-license inspections supporting Biologics License Application submissions and supplements as part of the CBER managed review process.
- Provides assessment of the compliance status of regulated establishments within CBER's purview (compliance status checks).
- Evaluates proposed proprietary names to avoid potential medication errors related to look-alike and sound-alike proprietary names and mitigating other factors that contribute to medication errors, such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design.
- Provides consultative reviews of proposed product labeling.
- Plans and conducts tests on biological products and conducts research to develop and improve procedures to evaluate the safety, efficacy, and purity of biological products.
- In cooporation with other Center components, as appropriate, tests biological products submitted for release by manufacturers.
Compliance-Related Policy Activities
- Advises the Center Director and other Agency officials on emerging and significant compliance issues for biological products and serves as CBER's focal point for surveillance and enforcement policy.
- Develops, with other CBER/Agency components, policies and compliance standards for biological products, including Current Good Manufacturing Practice (CGMP) regulations; ensures the uniform interpretation of standards and evaluates industry's conformance with CGMP in manufacturing biological products.
Within OCBQ, there are four Divisions, plus additional staff within the Immediate Office of the Director (IOD) of OCBQ:
- Division of Case Management (DCM)
- Division of Inspections and Surveillance (DIS)
- Division of Manufacturing and Product Quality (DMPQ)
- Division of Biological Standards and Quality Control (DBSQC)
- Immediate Office of the Director (IOD)
Additional Information about OCBQ
Additional information about OCBQ's responsibilities is available in FDA’s Staff Manual Guide.
- Overview of CBER's Compliance and Surveillance Activities
- FDA's Regulatory Procedures Manual (Searchable)
- FDA's Compliance Manuals
- Additional FDA References for Enforcement and Compliance Actions
- FDA Warning Letters (Searchable by Year Posted)
Untitled Letters (CBER)
- FDA Inspection Classification Database (Searchable)
- Administrative Actions for Biologics (including Notices of Intent to Revoke (NOIR) and HCT/P Orders)
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion CBER-Regulated Products: Shortages and Discontinuations Recalls (Biologics) Your Guide to Reporting Problems to FDA(PDF - 452KB) Questions about Blood
- CFR-Code of Federal Regulations Title 21 (Searchable)