Center for Biologic Evaluation and Research at USFDA has released its Annnual Summary Report for the Fiscal Year 2014.
FDA requires reporting of certain deviations and unexpected events in manufacturing in
accordance with 21 CFR 600.14, 606.171 or 1271.350(b).
Manufacturers of licensed biological products other than blood and blood components (licensed non-blood) who hold the biological product license for and had control over the product when a deviation or unexpected event occurred are required to submit Biological Product Deviation (BPD) reports (21 CFR 600.14)
tothe Center for Biologics Evaluation and Research (CBER), if the safety, purity, or potency of a distributed product may be affected. Licensed manufacturers of blood and blood components,including Source Plasma; unlicensed registered blood establishments; and transfusion serviceswho had control over the product when a deviation or unexpected event occurred are alsorequired to submit BPD reports (21 CFR 606.171), if the safety, purity, or potency of adistributed product may be affected. In addition, manufacturers of nonreproductive Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/P) regulated by FDA solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 are required to submit deviation reports [21 CFR 1271.350(b)] involving distributed products, if the deviation or unexpected event is related to a
Core CurrentGood Tissue Practice requirement[21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination.
Detailed information concerning deviation reporting, including guidance documents on BPD reporting for blood and plasma establishments (Ref. 1) and licensed manufacturers of biological products other than blood and blood components (Ref. 2), is available CLICK HERE.
This annual summary report provides an overview of the reports we received during the fiscal year, including detailed information regarding the number and types of deviation reports received.
We provide combined data received over the last three fiscal years in an effort to compare data and highlight changes.
Throughout the analysis, we report numbers from past reports, calculate changes, or consider aggregate counts from multiple BPD codes. These data may or may not be included in accompanying tables.
Detailed counts for all BPD codes can be found in the attachments and past summary reports are available CLICK HERE
