FDA publishes Biological Product and HCT/P Deviation Reports for Fiscal Year 2016

Quality and Safety of products by biological origin had an increasing importance in the near past. This can also be seen in the increasing number of guidance documents referring to this topic, like the guidances

Therefore, in accordance with the current requirements in 21CFR,  the manufacturers had to submit reports about deviations or unexpected events relating to safety, purity, or potency of a distributed product occuring under their responsibility. This includes the following establishments:

  • Manufacturers of licensed biological products other than blood and blood components (licensed non-blood) who hold the biological product license [21 CFR 600.14];
  • Licensed manufacturers of blood and blood components, including Source Plasma [21 CFR 606.171];
  • Unlicensed registered blood establishments [21 CFR 606.171]; and
  • Transfusion services [21 CFR 606.171].

Further, if is related to a Core Current Good Tissue Practice requirement [21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination, it also affects

  • 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 [21 CFR 1271.350(b)].

The FDA now published an annual summary report which provides an overview of the reports they received during the fiscal year, including detailed information regarding the number and types of deviation reports received. The FDA provides combined data received over the last three fiscal years in an effort to compare data and highlight changes.

In the time frame of FY 2016, the FDA entered more than 51.229 reports into their Biological Product Deviation (BPD) database. This was an increase of 10% (or 4.642 reports) compared to FY2015. For blood and source plasma establishments, it was an increase of 4.546 reports, for manufacturers of other licensed biological products an increase of 93 reports. In detail that was spread as follows:

  • Licensed blood establishments - four more reports in FY16.
  • Unlicensed registered blood establishments - 482 more reports in FY16.
  • Transfusion services - 130 more reports in FY16.
  • Source Plasma establishments - 3.930 more reports in FY16.


  • Allergenic manufacturers - seven more reports in FY16
  • Blood derivative manufacturers - 11 more reports in FY16.
  • Licensed in-vitro diagnostic manufacturers - 33 more reports in FY16.
  • Vaccine manufacturers - 42 more reports in FY16.
  • Licensed HCT/P manufacturers (351 HCT/P) - the same number of reports in FY16 as in FY15.
  • Cellular HCT/P manufacturers - the same number of reports in FY16 as in FY15.
  • Tissue HCT/P manufacturers - three more reports in FY16.

The total number of reporting establishments increased from 1.907 to 1.950. To learn more about the developments and see the tables with the comparison of the last three years, please see the complete "Biological Product and HCT/P Deviation Reports".

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