Vaccines, Blood & Biologics
Resources for You
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2012 Instructions for Using the eBPDR System Biological Product Deviation Reports Annual Summaries
- Biological Product Deviation Report Form (FDA Form 3486) (PDF - 757KB)
Compliance Programs (CBER) HCT/P Inspection Information
- Return to Office of Compliance and Biologics Quality (OCBQ) Page
Division of Inspections and Surveillance (DIS)
The Division of Inspections and Surveillance (DIS) within OCBQ has many responsibilities, including the following:
Inspection, Surveillance, and Compliance Activities
- Coordinates and provides support and direction to district offices for investigations and surveillance inspections. Supports the CBER pre-approval inspection program.
- Works with the Office of Regulatory Affairs (ORA) to prepare inspection work plans and allocate resources for the CBER inspection programs.
- Develops and updates CBER compliance programs, coordinates and directs their implementation, and advises other Agency components on these programs.
- Plans and directs investigation and surveillance assignments in response to reports regarding product defects, adverse events, complaints, biological product deviation reports, and allegations of violative activity. Evaluates the related inspection and investigation reports.
- Directs CBER’s Bioresearch Monitoring program with oversight of clinical investigators, institutional review boards, and sponsors of clinical research for biological products. Plans and directs inspection assignments, evaluates Establishment Inspection Reports, and takes appropriate compliance actions, in coordination with other Agency components, including Untitled Letters, Warning Letters, and the initiation of disqualification of clinical investigators.
Biological Product Deviation Reports (BPDRs) and Blood Collection and Transfusion Related Fatality Reports
- Directs CBER’s program for biological product deviation reports (including HCT/P deviation reports and medical device reports), and reports of complications of blood collection or transfusion confirmed to be fatal. Coordinates case reviews, as appropriate, by a committee of medical officers.
Additional Information about DIS
Additional information about the responsibilities of DIS is available in FDA’s Staff Manual Guide.
- Overview of CBER's Compliance and Surveillance Activities (Biologics)
- FDA's Regulatory Procedures Manual (Searchable)
- 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)
- How to Report Transfusion/Donation Fatalities
Report a Problem to CBER
- Tissue Reporting
- Biological Product Deviations (including HCT/P deviations)
FDA/ORA Bioresearch Monitoring Information Page Clinical Investigator Status (Biologics)
- CFR-Code of Federal Regulations Title 21 (Searchable)