The Division of Case Management (DCM) within OCBQ has many responsibilities, including the following:
Inspection, Surveillance, and Compliance Activities
- Reviews and evaluates administrative action recommendations including suspension, revocation, and denial of license. Reviews recommended civil and criminal actions, including seizure, injunction, and prosecution. Prepares documents required for such enforcement actions and manages cases after actions are taken.
- Develops enforcement standards for direct reference authority to the Office of Regulatory Affairs (ORA) for issuance of warning letters, and reviews and evaluates recommendations for the issuance of warning letters for which direct reference authority had not been granted.
- Directs the recall program for CBER-regulated products, including voluntary and FDA requested recalls, as well as orders for recall of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).
- Directs and coordinates CBER's import and export programs, including review of requests for export of unapproved biological products.
- Reviews, evaluates, and takes appropriate compliance actions on advertising and promotional labeling materials for CBER-regulated products to ensure that the information about the risks and benefits of regulated products are communicated in a truthful, accurate, science-based, non-misleading and balanced manner, and is in compliance with pertinent laws and regulations.
Pre- and Post-Market Approval Activities
- 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.
Additional Information about DCM
Additional information about DCM'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
- Types of Regulatory Action Letters that may be Issued by CBER
- FDA Warning Letters (Searchable by Year Posted)
- Untitled Letters (CBER)
- Administrative Actions for Biologics (including Notices of Intent to Revoke (NOIR) and HCT/P Orders)
- CFR-Code of Federal Regulations Title 21 (Searchable)
FR Notice, Vol. 43, No. 190, September 29, 1978: Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding (Final Rule)
- CBER Approved Products
Additional Compliance, Inspection, and Enforcement Resources
- FDA Manual of Compliance Policy Guides (Searchable)
- FDA's Debarment List
FDA's Application Integrity Policy
- FDA Inspection Observations, including Summaries By Fiscal Year
- FDA Inspection Classification Database (Searchable)
- FDA Enforcement Activity, including Enforcement Statistics by Fiscal Year
- FDA/ORA's Product Code Builder
- FDA Import and Export Guidance Documents