Biological Product Deviation 
Reporting for Blood and Plasma 
Establishments
 
 
 
Guidance for Industry 
 
 
This guidance is for immediate implementation. 
 
 
FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 
10.115(g)(2) without initially seeking prior comment because the agency has determined that 
prior public participation is not feasible or appropriate. 
 
FDA invites comments on this guidance.  Submit one set of either electronic or written 
comments on this guidance at any time.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  You should identify all comments with the docket number listed in the notice of 
availability that publishes in the Federal Register.  FDA will review any comments we receive 
and revise the guidance when appropriate. 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-
regulatory-information-biologics/biologics-guidances. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
March 2020   
 
 
Table of Contents  
  
  
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  REGULATORY REQUIREMENTS AND RECOMMENDATIONS ........................ 3 
A.  Who Must Report? (21 CFR 606.171(a)) ............................................................ 3 
Examples of who must report: ................................................................................ 4 
B.  What Do I Report? (21 CFR 606.171(b)) ............................................................ 7 
Biological Product Deviation Reporting Flow Chart for Blood and Plasma 
Establishments ........................................................................................................ 8 
C.  When Do I Report? (21 CFR 606.171(c)).......................................................... 14 
D.  How and Where Do I Report? (21 CFR 606.171(d) and (e)) .......................... 15 
IV.  EXAMPLES OF REPORTABLE AND NON-REPORTABLE EVENTS BY 
MANUFACTURING SYSTEM .................................................................................... 15 
A.  Donor Eligibility .................................................................................................. 16 
B.  Collection ............................................................................................................. 18 
C.  Component Preparation ..................................................................................... 19 
D.  Testing .................................................................................................................. 20 
E.  Labeling ............................................................................................................... 22 
F.  Quality Control (QC) and Distribution ............................................................ 23 
VI.  REFERENCES ................................................................................................................ 27 
 
  
 
 
    
 
i 
  Contains Nonbinding Recommendations  
Guidance for Industry 
 
Biological Product Deviation Reporting for Blood and Plasma 
Establishments 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  INTRODUCTION 
 
We, FDA, are providing you, a blood or plasma establishment, with revised recommendations 
related to biological product deviation (BPD) reporting.  This guidance document is intended to 
assist blood and plasma establishments in determining when a report is required, who submits 
the report, what information to submit in the report, the timeframe for reporting, and how to 
submit the report.  The revised guidance explains that we do not consider post donation 
information (PDI) events to require BPD reports.  PDI includes information that a donor, or 
other reliable source, provides to a blood establishment after a donation (e.g., at a subsequent 
donation) that would have resulted in deferral of the donor had you known the information at the 
time of donation.1  The revised guidance also contains other technical updates and editorial 
revisions to improve clarity and provide a more streamlined document.  FDA is also announcing 
the withdrawal of two obsolete memoranda to blood establishments entitled, Responsibilities of 
Blood Establishments Related to Errors & Accidents in the Manufacture of Blood & Blood 
Components, issued March 20, 1991, and Guidance Regarding Post Donation Information 
Reports, issued December 10, 1993.  
 
For the purposes of this document, blood and plasma establishment includes licensed 
manufacturers of blood and blood components, including Source Plasma, unlicensed registered 
blood establishments, and transfusion services.  This guidance document supersedes the 
guidance entitled Guidance for Industry: Biological Product Deviation Reporting for Blood and 
Plasma Establishments, dated October 2006.   
 
   
                                                 
1 Although FDA does not consider PDI events to require BPD reports under 21 CFR 606.171, FDA is aware that 
PDI events will continue to occur.  Blood establishments are required to comply with applicable regulations 
regarding, among other things, establishing, maintaining, and following standard operating procedures (see 21 CFR 
606.100(b)) and maintaining records (see 21 CFR 606.160).  FDA will continue to assess procedures and records 
associated with PDI events during routine inspections of blood establishments.  
1   Contains Nonbinding Recommendations  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory requirements 
are cited.  The use of the word should in Agency guidances means that something is suggested 
or recommended, but not required.  
 
 
II.  BACKGROUND 
 
Under 21 CFR 606.171,2, 3 you are required to report certain events associated with the 
manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding 
or distribution, of blood or a blood component, which may affect the safety, purity, or potency 
of a distributed product.  Safety, purity, and potency are defined in 21 CFR 600.3(p), (r), and (s), 
respectively.  
 
Under 21 CFR 606.171(c), you should submit reports as soon as possible, but you must submit 
reports at a date not to exceed 45 calendar days from the date of acquiring information 
reasonably suggesting a reportable event has occurred.  To facilitate reporting, we have 
developed a standardized reporting format that you may submit electronically or in paper form, 
by mail.  
 
You are required to evaluate and investigate, as appropriate, unexplained discrepancies and 
failures to meet specifications, and to maintain complaint records, including records of 
investigations and follow-up (21 CFR 606.100, 211.192 and 211.198).  Procedures for the 
investigation of any unexplained discrepancy or the failure of a lot or unit to meet any of its 
specifications should include provisions for:  
 
  a timely investigation;  
  an appropriate corrective action plan to prevent recurrence;  
  procedures to gain control of unsuitable products in a timely manner;  
  appropriate disposition of all affected products (in-date and expired);  
  an assessment of the donors eligibility to serve as a donor in the future, for 
deviations and discrepancies associated with donor eligibility.   
 
 
                                                 
2 See Ref. 1. 
3 Manufacturers of licensed biological products other than blood and blood components, including vaccines, 
allergenic products, therapeutics, plasma derivatives, and in vitro diagnostics (IVDs), are required to submit product 
deviation reports in accordance with 21 CFR 600.14, which contains requirements similar to those in 21 CFR 
606.171.  We have issued a separate guidance for reporting of product deviations by licensed manufacturers of 
biological products other than blood and blood components (Guidance for Industry:  Biological Product Deviation 
Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components, October 
2006) (Ref. 2).   
 
2   Contains Nonbinding Recommendations  
III.  REGULATORY REQUIREMENTS AND RECOMMENDATIONS 
 
A.  Who Must Report? (21 CFR 606.171(a)) 
  
Under 21 CFR 606.171, the manufacturer that had control over the product when the 
reportable event occurred must submit a report.  This reporting requirement applies to:  
 
  licensed manufacturers of blood and blood components, including Source 
Plasma;  
  unlicensed registered blood establishments; and  
  transfusion services.  
  
We define control in 21 CFR 606.3(l) as having responsibility for maintaining the 
continued safety, purity and potency of the product and for compliance with applicable 
product and establishment standards, and for compliance with current good 
manufacturing practices.  
 
If you are a plasma fractionator or in vitro diagnostic (IVD) manufacturer that 
manufactures Source Plasma or other blood components for further manufacture into 
another licensed biological product (e.g., Immune Globulin Intravenous (Human), 
Reagent Red Blood Cells), you are subject to reporting as specified in 21 CFR 
600.14(a)(2)(iii).  
 
Sometimes, a blood establishment establishes a contract with another entity to perform 
some or all of the manufacture of a product.  Some common manufacturing steps 
performed under contract include testing (e.g., relevant transfusion-transmitted infection4 
(RTTI) or compatibility)), irradiation, blood collection, storage and distribution.  If you 
contract out any manufacturing step, for the purposes of 21 CFR 606.171(a), that step is 
performed under your control.  Under 21 CFR 606.171(a), you must establish, maintain, 
and follow a procedure for receiving information from that person (e.g., a contract 
manufacturer) on all deviations, complaints, and adverse events concerning the affected 
product.  
 
For the purposes of 21 CFR 606.171(a), we do not consider contract manufacturing to 
include the supply of blood products to a transfusion service from a blood establishment 
or the supply of plasma to a fractionator from a blood establishment.  
 
For the purposes of 21 CFR 606.171(a), a blood establishment that performs 
compatibility testing for a transfusion service and makes the final determination 
regarding the suitability of a product for a specific patient and distributes the product to 
the transfusion service is not considered a contract manufacturer.  The blood 
establishment maintains the patient transfusion record and blood unit disposition history 
for the transfusion service.  In this case, the blood establishment would be responsible for 
                                                 
4 See 21 CFR 630.3(h). 
3   Contains Nonbinding Recommendations  
submitting reports related to the manufacturing steps it performs.  The transfusion 
service would be responsible for reporting events related to the manufacturing steps it 
performs, such as storage and distribution.  
 
If you are a contract manufacturer (i.e., under contract, you perform manufacturing for 
another establishment), you must conduct such manufacturing in accordance with current 
good manufacturing practice (CGMP) (21 U.S.C. 351(a)(2)(B)), but you are not required 
to report BPDs to us.  
 
Examples of who must report:  
  
1.  EVENT 
You are a blood establishment that contracts with a test laboratory to have 
the laboratory perform RTTI testing, including nucleic acid testing 
(NAT).  The test laboratory did not perform the testing in accordance with 
the test kit manufacturers instructions or its own procedures.  The test 
laboratory used the incorrect incubation time.  Failure to follow the test 
kit instructions or validated procedures may affect the safety, purity, or 
potency of the product.  
 
REPORTING 
Under 21 CFR 606.100(c), 211.192, and 211.198, the test laboratory must 
perform an investigation.  The test laboratory is NOT required to report to 
us.  The test laboratory would provide the blood establishment with 
details of the deviation in RTTI testing.  
 
Under 21 CFR 606.171(a), you must establish, maintain, and follow a 
procedure for receiving information from the test laboratory about 
deviations concerning the RTTI testing.  Under 21 CFR 606.171(b), you 
must submit a report to us if you distributed the improperly tested 
product.  We recommend that you assure that the test laboratory 
performed an adequate investigation.  
  
2.  EVENT 
You are a blood establishment that contracts with another blood 
establishment (referred to as an irradiator) to perform irradiation of blood 
products.  You sent a product to the irradiator.  After irradiation, the 
product was returned to you.  The irradiator notified you that the incorrect 
dosage was used which may affect the safety, purity, or potency of the 
product.  
  
REPORTING  
Under 21 CFR 606.100(c), 211.192, and 211.198, the irradiator must 
perform an investigation.  The irradiator is NOT required to report to us.  
4   Contains Nonbinding Recommendations  
The irradiator would provide you with details of the deviation in the 
irradiation process.  
  
Under 21 CFR 606.171(a), you must establish, maintain, and follow a 
procedure for receiving information from the irradiator about deviations 
concerning the irradiation process.  Under 21 CFR 606.171(b), you must 
submit a report to us if you distributed the improperly irradiated product.  
We recommend that you assure that the irradiator performed an 
appropriate investigation.  
 
3.  EVENT  
You are a blood establishment that distributed a blood product to another 
blood establishment (referred to as an irradiator), which subsequently 
irradiated it.  The irradiator used the incorrect dosage during irradiation 
which may affect the safety, purity, or potency of the product.  
 
REPORTING  
Under 21 CFR 606.100(c), 211.192, and 211.198, the irradiator must 
perform an investigation.  Under 606.171(b), the irradiator must submit a 
report to us if it distributed the improperly irradiated product.  You are 
NOT required to report to us or perform an investigation because the 
product was not in your control at the time the event occurred, i.e., it was 
not irradiated under a contract manufacturing agreement.  
  
4.  EVENT  
You are a transfusion service that received a unit of Platelets from a blood 
establishment.  When you received the product, you discovered that the 
product was labeled with an improperly extended expiration date, which 
may affect the safety, purity, or potency of the product.  You notified the 
blood establishment.  
 
REPORTING  
Under 21 CFR 606.100(c), 211.192, and 211.198, the blood establishment 
must perform an investigation of the labeling deviation.  Under 21 CFR 
606.171(b), the blood establishment must submit a report to us.  
  
You are NOT required to report to us unless you distributed the unit 
without correcting the label.  
  
5.  EVENT  
You are a transfusion service that received 10 units of Platelets and 
subsequently pooled them to create Pooled Platelets.  You improperly 
labeled the Pooled Platelets with an extended expiration date, which may 
affect the safety, purity, or potency of the product.  
  
5   Contains Nonbinding Recommendations  
REPORTING  
Under 21 CFR 606.100(c), 211.192, and 211.198, you must perform an 
investigation of the deviation in labeling.  Under 21 CFR 606.171(b), you 
must submit a report to us if you distributed (i.e., issued for transfusion) 
the mislabeled product.  
 
6.  EVENT  
You are a transfusion service that received a unit of Red Blood Cells from 
a blood establishment.  The unit was labeled with an improperly extended 
expiration date (for example, 54 days instead of 42 days) but you did not 
recognize this before crossmatching and distributing the unit to the 
surgical floor.  The surgical floor questioned the expiration date of the 
unit and returned the unit to the blood bank, at which time the improperly 
extended expiration date was discovered.  This may affect the safety, 
purity, or potency of the product.  
 
REPORTING  
Under 21 CFR 606.100(c), 211.192, and 211.198, you must perform an 
investigation of the inappropriate release of a product with an improperly 
extended expiration date.  Under 21 CFR 606.171(b), you must submit a 
report to us because the product was in your control at the time of such 
inappropriate release.  We recommend that you notify the blood 
establishment of the incorrect labeling.  
 
Under 21 CFR 606.100(c), 211.192, and 211.198, the blood establishment 
must perform an investigation of the deviation in labeling.  Under 21 CFR 
606.171(b), the blood establishment must also submit a report to us, since 
the product was in the blood establishments control at the time of the 
labeling deviation 
 
7.  EVENT  
You are a Source Plasma collection establishment that tested a unit of 
Source Plasma and distributed it to a fractionator.  You discovered that 
one of the RTTI tests was incorrectly performed.  Repeat testing of a 
reserve sample was positive for the RTTI.  The safety, purity, or potency 
of the Source Plasma may be affected.  
 
REPORTING  
Under 21 CFR 606.100(c), you must perform an investigation of the 
improper testing and distribution of the unit.  Under 21 CFR 606.171(b), 
you must submit a report to us.  We recommend that you evaluate the 
need for product retrieval or notification to the fractionator.  Note:  If your 
contract testing laboratory performed the testing, you would be the 
reporting establishment.  
  
6   Contains Nonbinding Recommendations  
The fractionator would submit a report under 21 CFR 600.14, if it used 
the improperly tested plasma unit in the manufacture of a licensed 
biological product and distributed the final product.  The use of the 
improperly tested plasma would represent an unexpected or unforeseeable 
event that may affect the safety, purity, or potency of the final product 
(see footnote 2).  
 
B.  What Do I Report? (21 CFR 606.171(b)) 
  
Under 21 CFR 606.171(b), you must report any event, and information relevant to the 
event, associated with the manufacturing, to include testing, processing, packing, 
labeling, or storage, or with the holding or distribution, of both licensed and unlicensed 
blood or blood components, including Source Plasma, if that event meets all the 
following criteria:  
  
(1) Either  
(i)  Represents a deviation from CGMP, applicable regulations, 
applicable standards, or established specifications that may affect 
the safety, purity, or potency of that product; or  
(ii)  Represents an unexpected or unforeseeable event that may affect 
the safety, purity, or potency of that product; and  
(2) occurs in your facility or a facility under contract with you; and  
(3) involves distributed blood or blood components.  
  
An adequate procedure for deviation reporting (21 CFR 606.100(b)) should include steps 
for determining whether an event is one for which a report must be submitted.  The 
decision to report should be based on whether the event had the potential to affect the 
safety, purity, or potency of a product.  The terms safety, purity, and potency are defined 
in 21 CFR 600.3(p), (r), and (s), respectively.  
  
Retrieval, Consignee Notification and Lookback 
  
You are not required to submit a BPD report simply because you failed to follow your 
own internal procedures for retrieval, notification or lookback (e.g., you do not have to 
submit a report if you did not notify consignees within the time frame prescribed in your 
procedures).  The failure to follow retrieval, notification, or lookback procedures does 
not, by itself, affect the safety, purity, or potency of the product.  However, you must 
submit a report if the underlying reason for the retrieval, notification, or lookback meets 
the reporting criteria in 21 CFR 606.171(b).  In that case, the report must describe the 
event that may have affected the safety, purity, or potency of the distributed product.  For 
example, you distributed a product inappropriately collected from a donor with a history 
of high-risk behavior, which may affect the safety, purity, or potency of the product.  
You did not notify consignees within the timeframe described in your internal  
   
7   Contains Nonbinding Recommendations  
procedures.  You are not required to report the failure to follow your internal consignee 
notification procedures; however, you are required to report the improper release of the 
product.  
  
You are not required to submit a report:  
 
1.  When you did not distribute potentially affected products, regardless of the 
event.  
2.  When you determined, prior to distributing the product, that the event did not 
actually affect the safety, purity, or potency of the product.  
3.  When you detected the event and prior to distribution, made the appropriate 
corrections.  
4.  When the event was related to donor safety only and did not have the 
potential to affect the safety, purity, or potency of the product.   
5.  If your report would simply state that you were late in reporting the event to 
us.   
6.  If you receive information, after a donation, that would have resulted in 
deferral of the donor had you known the information at the time of the 
donation (post donation information). 
7.  If you receive information of a post donation illness. 
8.  For a recordkeeping deviation that would not affect the safety, purity, or 
potency of the product. 
 
While the above examples would not be reportable under 21 CFR 606.171, the events 
may constitute deviations from the regulations, which we would assess during 
inspection.  
  
Biological Product Deviation Reporting Flow Chart for Blood and Plasma 
Establishments  
  
You may use the following flow chart to help you determine if you are required to report 
an event to us.  
  
   
8   Contains Nonbinding Recommendations 
Biological Product Deviation Flow Chart for Blood and Plasma Establishments5 
potency of a 
product?  
5 For purposes of this flowchart, and the corresponding discussion below regarding the questions in this flowchart, 
an event is a deviation from current good manufacturing practice, applicable regulations, applicable standards, or 
established specifications, or an unexpected or unforeseeable event.  
9  Contains Nonbinding Recommendations  
 
The following questions correspond to the flow chart:  
  
(1) Was the event associated with manufacturing or holding or 
distribution as they are described in the regulation?  
  
As described in 21 CFR 606.171(b), manufacturing includes testing, processing, 
packing, labeling, or storage.  In addition, you must report events associated with 
the holding or distribution of both licensed and unlicensed blood or blood 
components, including Source Plasma.  
   
Under 21 CFR 606.171, you are not required to report events that occur after you 
distribute the product, including those related to the administration of blood or 
blood components.  
  
Examples   
1.  A Transfusion Service is NOT required to report to us if the event 
occurs during transfusion or administration procedures, after the blood 
product has left the control of the transfusion service.  For example, a 
report is not required:  
  
  If the transfusion service issued a product from the laboratory to 
the nursing floor, operating room or emergency room, etc., for 
transfusion and the product was not held at the appropriate 
temperature outside of the transfusion service prior to transfusion.  
However, the transfusion service is required to report if the 
product was returned and the transfusion service reissued the 
product despite determining it to be unsuitable.  
  
  If the hospital staff, outside of the transfusion service, transfused 
the wrong patient or transfused a patient with the wrong unit, 
provided the unit was labeled appropriately and the transfusion 
service conducted compatibility testing properly.  If a 
complication of a transfusion was confirmed to be fatal, the 
facility that performed the compatibility testing must submit a 
fatality report to us in accordance with 21 CFR 606.170(b).  
  
  If the transfusion service issued a filter with the product and the 
hospital staff did not use the filter at the bedside.  
  
  If the patient has a transfusion reaction that is not related to an 
event in manufacturing.  Fatalities due to Transfusion Related 
Acute Lung Injury (TRALI) or other transfusion complications 
must be reported to CBER in accordance with 21 CFR 
10   Contains Nonbinding Recommendations  
606.170(b). We also accept voluntary reports of non-fatal TRALI 
as a serious adverse reaction to transfusions.  Such voluntary 
reports can be submitted via MedWatch (see FDAs website at 
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?actio
n=reporting.home.   
For additional information related to TRALI, see the Dear 
Colleague letter published October 19, 2001 at 
https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/
BloodSafety/ucm095556.htm.  
  
2.  A Blood Establishment is NOT required to report if the event is 
not associated with its manufacturing process and did not occur while the 
product was under the control of the blood establishment.  For example, a 
report is not required:  
  
  If the blood establishment distributed a product to a transfusion 
service and the transfusion service stored the product at the 
incorrect temperature.  However, under 21 CFR 606.171(b), if the 
transfusion service distributed the product, the transfusion service 
must report to us.  
  
  If the blood establishment received an unacceptable product (for 
example, a hemolyzed unit) from another blood establishment, 
identified the discrepancy and returned or discarded the product.  
Under 21 CFR 606.171(b), the blood establishment that 
distributed the unacceptable product, but not the establishment that 
received and returned or discarded it, must report to us.  
  
(2a) Was there a deviation that may affect the safety, purity, or potency of a 
product?  
  
A deviation that may affect the safety, purity, or potency of a product could 
include any change in the manufacturing process that could prevent a product 
from meeting all CGMP requirements, applicable standards, and established 
specifications.  The CGMP requirements and applicable standards for blood and 
blood components are currently found in 21 CFR Parts 210, 211, 600, 606, 610, 
630, and 640.   
  
(2b) Was there an unexpected or unforeseeable event that may affect the 
safety, purity, or potency of a product?  
  
An unexpected or unforeseeable event is one in which, despite the fact that you 
followed all required procedures, something unanticipated occurred that may 
affect the safety, purity, or potency of a product.  This may be due to information 
11   Contains Nonbinding Recommendations  
that you did not have at the time of manufacturing.  The following is an example 
of an unexpected or unforeseeable event in which the safety, purity, or potency 
may be affected:  
  
  After you distributed a product, your materials vendor informed 
you that materials used in the collection or processing of blood 
and blood components, such as reagents, soft goods, software, or 
the collection device, did not meet all requirements or 
specifications, and you could not have detected the problem during 
your routine incoming material qualification procedures.  
  
If an event occurred, but could not have affected the safety, purity or potency of a 
product, you must record and investigate the event in accordance with 21 CFR 
606.160(b)(7)(iii), 606.100(c), 211.192 and 211.198, but you do not need to 
report to us.  
  
Under 21 CFR 606.171(b), if you discover an event that may affect safety, purity, 
or potency of the product after you have distributed a product, you must report 
the event, regardless of whether consignee notification or product retrieval is 
necessary.  You must report the event even if you ultimately determine, through 
investigation after distribution, that the safety, purity or potency of the product 
was not affected.  
  
For example, if you distributed a product that was not tested for RTTI, you must 
submit a report to us under 21 CFR 606.171(b), even if you subsequently tested 
the product and found it to be negative  
  
If you discover an event prior to distribution of a product and determined that the 
event did not affect the safety, purity, or potency of the products, you are not 
required to report under 21 CFR 606.171.  
  
For example, if you discovered a deviation in testing prior to the distribution of a 
product and you appropriately retested a donor blood sample collected at the 
same time as the product and found it to be negative, you are not required to 
report to us under 21 CFR 606.171.  
  
(3) Did the event occur in your facility or in a facility under contract with 
you?  
  
You are required to submit a report if the event occurred within your facility or a 
facility under contract to perform a manufacturing, holding, or distribution step, 
such as a testing laboratory.  Under 21 CFR 606.171(a) and (b), you must report 
events that occur at the contract facility and you must establish, maintain, and 
follow a procedure for receiving information from the contract facility on all 
deviations, complaints, and adverse events concerning the affected product.  
12   Contains Nonbinding Recommendations  
  
If you are a contract manufacturer, such as a testing laboratory, and an event 
occurs within your facility, you would notify the manufacturer(s) with control 
over the product, if its products may be affected.  You are not responsible for 
reporting the event to us.  
  
If you detect an event that occurred in another facility not under contract with 
you, we recommend that you contact that facility, which would be responsible for 
reporting to us, if appropriate.  For example, if you receive a unit of Red Blood 
Cells distributed without ice we recommend that you notify the supplier.  You are 
not required to report to us unless you further distributed the unacceptable unit.  
  
(4) Did you have control over the product when the event occurred?  
  
You have control, as defined in 21 CFR 606.3(l), over the product if you have 
overall responsibility for:   
 
  maintaining the continued safety, purity, and potency of the product, 
  compliance with applicable product and establishment standards, and  
  compliance with CGMP.  
  
You are responsible for reporting if you had control over the product when the 
event occurred, and you distributed the affected product.  
  
You have control over the product if you contract with another entity to perform 
all or some of the manufacture of a product.  Under 21 CFR 606.171(a), you must 
establish, maintain, and follow a procedure for receiving information from the 
contract manufacturer on all deviations, complaints and adverse events.  The 
contract manufacturer is responsible for documenting the event in accordance 
with 21 CFR 606.160(b)(7)(iii) and investigating in accordance with 21 CFR 
606.100(c), 211.192 and 211.198.  The contract manufacturer is not responsible 
for reporting to us under 21 CFR 606.171.  
  
(5) Was the product distributed?  
  
We define distributed in 21 CFR 606.3(k) as:  
 
(1) the blood or blood component has left the control of the licensed 
manufacturer, unlicensed registered blood establishment, or transfusion 
service; or  
(2) the licensed manufacturer has provided Source Plasma or any other blood 
component for use in the manufacture of a licensed biological product.  
  
13   Contains Nonbinding Recommendations  
If you are a licensed blood establishment, a product is considered distributed 
when you ship the product to another facility or broker that is not part of your 
license or issue the product to staff outside the blood establishment for 
transfusion.  A product is not considered distributed if it was shipped from one 
location to another and both locations are under the same license.  
  
If you are an unlicensed blood establishment, including a transfusion service, a 
product is considered distributed when you issue the product to staff outside of 
the blood establishment for transfusion or you ship it to another facility or broker.  
  
If you collect Source Plasma or other products for further manufacture, the 
product is considered distributed when you release or ship the product for further 
processing.  Distribution includes shipment to a plasma broker.  Distribution does 
not include shipment to an off-site storage facility if the product is still under 
your control.  
  
Examples:  
  
  If a blood establishment labeled a product with an improperly 
extended expiration date and distributed it to a transfusion service, 
under 21 CFR 606.171(b) the blood establishment must report to us.  
  
  If a transfusion service received 10 units of platelets from a blood 
establishment, pooled the platelets, mislabeled the final Pooled 
Platelet container with an improperly extended expiration date, and 
issued the product to the nursing staff for transfusion, under 21 CFR 
606.171(b) the transfusion service must report to us.  However, if the 
transfusion service detected and corrected the expiration date before 
distributing the product, under 21 CFR 606.160(b)(7)(iii), 606.100(c), 
211.192, and 211.198, the transfusion service must document and 
investigate the deviation but is not required to report to us.  
  
If you distributed the product, we recommend that you also assess the need for 
product retrieval or consignee notification in accordance with 21 CFR Part 7.  
You must document the event in accordance with 21 CFR 606.160(b)(7)(iii) and 
investigate in accordance with 21 CFR 606.100(c), 211.192 and 211.198, 
regardless of whether you distributed the product.  
  
C.  When Do I Report? (21 CFR 606.171(c))  
  
Under 21 CFR 606.171(c), you should report a BPD as soon as possible, but you must 
report at a date not to exceed 45 calendar days from the date that you, your agent, or 
another person who performs a manufacturing, holding, or distribution step under your 
control, acquire information reasonably suggesting that a reportable event has occurred.  
You acquire such information when any employee of your facility, not just those 
14   Contains Nonbinding Recommendations  
involved in quality assurance or quality control activities, learns about the event.  As 
soon as you acquire information, you should assess whether the event had the potential 
to affect the safety, purity, and potency of products and determine the status of the 
products (i.e., whether they have been distributed or need to be quarantined).  
  
If you contract with a facility to perform a manufacturing, holding, or distribution step 
and an event occurs at the contractor, the time period for reporting starts when your 
contractor learns about the event.  
  
D.  How and Where Do I Report? (21 CFR 606.171(d) and (e))  
  
Under 21 CFR 606.171(d), you must use Form FDA-3486 to report BPDs.  You must 
submit the completed report either electronically through CBERs web site at  
https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-
evaluation-research/biological-product-deviations or by mail to:  
  
Food and Drug Administration  
Center for Biologics Evaluation and Research  
Document Control Center 
10903 New Hampshire Avenue 
Silver Spring, Maryland 20993-0002   
  
If the event occurred at your contract manufacturer, we recommend that you include in 
the report the details reported to you by the contract manufacturer regarding the event.  
  
Complete a separate report for each event.  If an event involves more than one product, 
you only need to complete one report listing all distributed products affected.  
  
The Form FDA-3486 and instructions for completing both formats are located at  
https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-
evaluation-research/biological-product-deviations. 
  
  
IV.  EXAMPLES OF REPORTABLE AND NON-REPORTABLE EVENTS BY 
MANUFACTURING SYSTEM  
  
We categorize BPD reports according to where in the manufacturing system the event occurred.  
Following the bulleted list below, each system is explained further, and we provide examples of 
both reportable and non-reportable events.  An event may be the result of a failure within a 
variety of systems.  It is important for you to know both where the event occurred and why your 
product was allowed to continue through the manufacturing process and be distributed, so that 
you can implement the appropriate corrective action to prevent recurrence.  
  
15   Contains Nonbinding Recommendations  
  A donor eligibility event occurs in the donor eligibility process (for example, donor 
screening, and donor deferral procedures) (see section IV.A of this guidance).  
  
  A collection event occurs during the collection process (see section IV.B of this 
guidance).  
  
  A component preparation event occurs during the component preparation process (see 
section IV.C of this guidance).  
  
  A testing event occurs during the testing process and includes sample deviations and 
unexpected events (see section IV.D of this guidance).  
  
  A labeling event occurs during the labeling process, which includes identifying the 
information to include on the label, printing the label, and applying the label to the 
product (see section IV.E of this guidance).  
  
  A quality control and distribution event involves a failure in either the quality control 
(QC) or distribution systems.  This category includes the distribution of a product that 
did not meet specifications (see section IV.F of this guidance).   
  
The following examples of events are not all-inclusive and do not represent all variations that 
may occur.  The examples include deviations from CGMP, applicable regulations, applicable 
standards, and established specifications, in addition to unexpected or unforeseeable events.  Not 
all of these examples will necessarily apply to you or to all products you manufacture.  
  
A.    Donor Eligibility  
  
Donor eligibility events are those that occur during donor screening or donor deferral 
which you did not discover until after you distributed the product.  
   
This category includes events concerning the medical history interview or physical 
assessment, blood donor record documentation, and deferral process.  
  
1.  Medical history interview process  
  
Under 21 CFR 606.171(b), you must submit a report when there is an 
event (a deviation or unexpected or unforeseeable event) that occurs 
during the medical history interview process that may affect the safety, 
purity, or potency of a product you distributed.  Examples of reportable 
events associated with the interview process may include:  
  Donor provided information that warranted deferral, but the donor 
was inappropriately determined eligible.  
16   Contains Nonbinding Recommendations  
  Donor provided incomplete information that was not resolved by 
follow-up questioning, and the donor was inappropriately 
determined eligible.  
  
2.  Physical assessment  
  
Under 21 CFR 606.171(b), you must submit a report when there is an 
event (a deviation or unexpected or unforeseeable event) that occurs 
during the physical assessment that may affect the safety, purity, or 
potency of a product you distributed.  Examples of reportable events 
associated with the physical assessment may include:  
  Donors hemoglobin or hematocrit was unacceptable.  
  Donors temperature was unacceptable.  
  Plateletpheresis donor had an unacceptable platelet count and there 
was no documented platelet count for the product.  
  Physical assessment was not performed or was inadequate.  
  
3.  Donor record documentation  
  
Under 21 CFR 606.171(b), you must submit a report when there is an 
event (a deviation or unexpected or unforeseeable event) in donor record 
documentation that may affect the safety, purity, or potency of a product 
you distributed.  Examples of reportable events associated with donor 
record documentation may include:  
  No documentation of donors hemoglobin, hematocrit, 
temperature, arm inspection.  
  Answers to the donor history questions, including high risk 
questions, were missing or incomplete, except those only affecting 
donor safety (e.g., history of pregnancy or heart disease).  
  Donor record was incomplete or incorrect  
 
4.  Deferral process 
  
Under 21 CFR 606.171(b), you must submit a report when there is an 
event (a deviation or unexpected or unforeseeable event) during the 
deferral process that may affect the safety, purity, or potency of a product 
you distributed.  Examples of reportable events associated with the 
deferral process, where the donor subsequently donated, may include:  
  Donor was incorrectly omitted from the deferral list.  
  Deferral list contained inaccurate information, such as temporary 
deferral instead of permanent deferral.  
  The donor tested positive for an RTTI, and an appropriate reentry 
algorithm was not followed.  
17   Contains Nonbinding Recommendations  
  Incorrect donor identification information was used to check the 
deferral list (regardless of whether the donor was previously 
deferred).  You would report even if the donor provided discrepant 
identification information, such as different names on two 
donations for example, J. Michael Smith and James M. Smith.  
  The deferral list was not checked (regardless of whether the donor 
was previously deferred).  
  
DO NOT REPORT:  
  Autologous donor did not meet the eligibility criteria and the medical director 
authorized acceptance of the donor in accordance with 21 CFR 630.20(a), 
provided the product was labeled appropriately and not crossed over for 
allogeneic use.  
  Donor did not meet eligibility criteria related to donor safety only, such as 
donors weight, age, or donation frequency.  These criteria do not affect 
product quality.  
  Plateletpheresis donor had an unacceptable platelet count, but the platelet 
count performed on the product was acceptable.  
  The record of deferred donors was not checked, or incorrect information was 
used to check record of deferred donors and you determined prior to 
distribution of products from that donation that the donor was not previously 
deferred.  
  Donor was accepted on the basis of incomplete information and you obtained 
additional information from the donor, prior to distribution of any products, 
demonstrating that the donor was acceptable.  
  Donor was deferred, and no products were collected.  Donor was not placed 
on the deferral list, but the donor did not have subsequent donations, therefore 
there were no products affected.  
  Reports of PDI. 
 
B.  Collection  
  
Collection events include those that occur during the collection process, which you did 
not discover until after you distributed the product 
  
Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation 
or unexpected or unforeseeable event) during the collection process that may affect the 
safety, purity, or potency of a product you distributed.  Examples of reportable events 
associated with the collection process may include:  
  
  Product was contaminated or potentially contaminated with bacteria or air. 
(The manufacturer that had control of the product during collection would be 
responsible for reporting this.)  
18   Contains Nonbinding Recommendations  
  Arm preparation was not performed or was performed incorrectly.  
  Outdated bag or collection set was used in collection.  
  Outdated or incorrect anticoagulant was used in collection.  
  Defective device or collection bag was used for collection.  
  Donor was over bled, and the product was distributed as Whole Blood. 
(Product may be affected if there was an inadequate volume of anticoagulant 
in the collection bag.)  
  *Product was discovered to be clotted.  
  **Product was discovered to be hemolyzed.  
 
* The manufacturer who had control of the product during collection would 
be responsible for reporting clotted products that were distributed. 
**The manufacturer who had control of the product during collection, 
component preparation and storage would be responsible for reporting 
hemolyzed products that were distributed and were not accepted into the 
consignees inventory.  A transfusion service would be responsible for 
reporting hemolyzed products if the product was inspected upon receipt from 
the collection facility and found acceptable (no hemolysis) and then later 
found to be hemolyzed while in the control of the transfusion service and 
subsequently distributed (reported under QC & Distribution system).  
  
DO NOT REPORT:  
  A recordkeeping deviation that would not affect the safety, purity, or potency 
of the product, such as the identification of the phlebotomist was missing 
from the donor record.  
  Donor has a reaction during the collection procedure.  If the donor has a fatal 
reaction as a result of a complication of blood collection, a BPD report is not 
required, but the collection facility must report to CBER in accordance with 
the requirements for reporting fatalities (21 CFR 606.170(b)).  
  
C.  Component Preparation  
  
Component preparation events include those that occur during the preparation or 
processing of a product, which you did not discover until after you have distributed the 
product.  
  
Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation 
or an unexpected or unforeseeable event) during the component preparation process that 
may affect the safety, purity, or potency of a product you distributed.  Examples of 
reportable events associated with the component preparation process may include:  
  
  Component, such as Platelets or Fresh Frozen Plasma, was not prepared 
within the appropriate time frame after collection.  
19   Contains Nonbinding Recommendations  
  Product was contaminated with bacteria, air or other contaminants during 
component preparation or processing, such as pooling. (The manufacturer 
that had control of the product during the component preparation process 
would be responsible for reporting this.)  
  Component was not manufactured according to established procedures 
such as:  
-  Platelets were prepared from a Whole Blood product collected from a 
donor who took aspirin or other drugs that affect platelet function and 
the unit was not labeled to identify the ingested drug that adversely 
affects platelet function;  
-  Fresh Frozen Plasma or Cryoprecipitated AHF did not meet freezing 
time requirements;  
-  Component manufactured from a Whole Blood unit that did not meet 
specifications, such as;  
  Overweight or underweight Whole Blood unit,  
  Whole Blood unit was stored at unacceptable temperature,  
-  Incorrect filter was used for leukoreduction;  
-  Product was not leukoreduced within the appropriate time frame;  
-  Incorrect dosage was used for irradiation; 
-  Product was not washed/deglycerolized properly.  
 
DO NOT REPORT:  
  The signature of the person preparing the product was missing.  
  
D.  Testing  
  
Testing events include those that occur during the testing process which you did not 
discover until after you distributed the product.  Testing includes all tests used to assure 
the safety, purity, and potency of a product (e.g., testing requirements in 21 CFR 610.40, 
640.5, and 606.151).  Use of unsuitable or inappropriate samples may be testing 
deviations or unexpected events. 
  
Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation 
or unexpected or unforeseeable event) during testing that may affect the safety, purity, or 
potency of a product you distributed.  Examples of reportable events associated with 
testing may include:  
  
  Testing was not performed in accordance with test manufacturers 
instructions, such as  
-  Incorrect incubation time or temperature was used;  
-  Incorrect reagent was used/licensable components from two different 
test kit lots were used;  
20   Contains Nonbinding Recommendations  
-  Incorrect addition of reagents (incorrect sequence, volume or 
concentration).  
-  Initial reactive was not repeated in duplicate (RTTI testing), when 
required by test manufacturers instructions.  
  Testing was incomplete, not performed, or not documented. 
  Sample was tested not in accordance with the manufacturers package 
insert (e.g., repeated testing until you obtained negative result).  
  Test results were inappropriately invalidated.  
  Sample that did not meet specifications for testing was used, such as  
-  Sample was improperly stored;  
-  Sample was diluted (for example, diluted with saline after an 
apheresis procedure);  
-  Sample was labeled with the wrong donor or patient identifier.  
  Testing was performed using a reagent or test kit in which QC was 
unacceptable or not documented.  This may include situations in which 
QC testing was not performed or was not documented on one day, even if 
the QC testing the day before and the day after was acceptable.  
  Testing was performed using expired reagents.  
  
For transfusion services, reportable events may include:  
  Patient samples were mislabeled or collected from the wrong patient and 
were used to perform pretransfusion testing and a product was distributed 
based on that testing.  This may include samples collected by transfusion 
service personnel and personnel outside of the blood establishment.  
  Patient typing results or compatibility testing results were misinterpreted, 
and a product was distributed based on that testing.  
  Antibody screen or identification testing on recipient, as set forth in your 
procedures, was not performed or was incomplete prior to distribution of 
product. 
  Product with no historical antigen typing was not tested for an antigen 
which corresponds to the patients antibody, as set forth in your 
procedures. 
  Immediate spin crossmatch was performed when a patients history or 
testing results indicated that an indirect antiglobulin test is needed.  
  
DO NOT REPORT:  
 
  You appropriately invalidated results of an assay and you retested samples 
and they tested negative before the product was distributed.  
  
 
 
21   Contains Nonbinding Recommendations  
E.  Labeling  
  
Labeling events include those that occur during the labeling process, which you did not 
discover until after you distributed the product.  Labeling events include incorrect, 
missing or misleading information on any product labeling, including:  
  the container label;  
  tie tags  
  the circular of information;  
  the labeling accompanying the product that identifies the patient for 
whom it has been crossmatched (transfusion record).  
  
Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation 
or unexpected or unforeseeable event) during labeling that may affect the safety, purity, 
or potency of a product you distributed.  Examples of reportable events associated with 
labeling may include:  
  Labeling contains an incorrect ABO group or Rh type, antigen type, 
antibody, anticoagulant, volume or expiration date.  
  Information is missing from the labelingsuch as ABO group or Rh type, 
expiration date, or volume.  
  Labeling indicates additional testing was performed, but the product was 
not tested as described in the labeling (for example, for CMV).  
  Product was tested but labeling showed testing information that is not 
consistent with the test results.   
  Labeling indicates an incorrectly extended expiration date, even if the 
product was transfused within the correct dating period.  
  Labeling indicates the product is crossmatch compatible when the product 
was either not crossmatched or was found to be incompatible.  
  Labeling indicates incorrect recipient name or identification number.  
  Labeling indicates an incorrect or missing donor/unit number.   
  Labeling indicates an incorrect product name or product name is missing, 
for example:  
-  Apheresis Platelets labeled as Plasma;  
-  Red Blood Cells labeled as Irradiated Red Blood Cells;  
-  Red Blood Cells labeled as Red Blood Cells Leukocytes Reduced, but 
product was not leukoreduced.  
 
DO NOT REPORT:  
  Labeling indicated a shortened expiration date  
  Provided the product is otherwise acceptable and the expiration date is 
correct, do not report missing or incorrect collection date or facility 
identification.  
  Unlicensed product incorrectly labeled with a US license number.  
 
22   Contains Nonbinding Recommendations  
F.  Quality Control (QC) and Distribution  
  
Under 21 CFR 606.171(b), you must submit a report when there is an event (a deviation 
or unexpected or unforeseeable event) during or related to QC procedures or in the 
quarantine and distribution process that may affect the safety, purity, or potency of a 
product you distributed.  Examples of reportable events associated with QC or 
distribution process may include:  
 
  The distribution of a product that was processed using an instrument or reagent 
for which QC was unacceptable, not documented or not performed. For example:  
-  No documentation that weekly QC was performed, even if daily QC tasks 
were performed and documented;  
-  No documentation of daily QC of trip scales used to weigh whole blood 
collections, unless the product was weighed prior to distribution and 
found acceptable.  
  The distribution of a product in which QC testing was unacceptable, not 
performed, not documented, or incomplete.  For example:  
-  pH (monthly QC of platelets);  
-  Platelet count.  
  Inappropriate release from quarantine, and distribution of, a product which was 
identified as not meeting specifications due to a deviation or unexpected event in 
donor eligibility, collection, component preparation, testing, or labeling.  For 
example:  
-  Failure to quarantine and distribution of a unit collected from a donor that 
was determined to be ineligible due to unacceptable donor medical 
history; 
-  Failure to quarantine and distribution of a unit/component that was 
overweight or underweight;  
-  Failure to quarantine and distribution of a component prepared from a 
Whole Blood unit in which one of the components was determined to be 
clotted or hemolyzed;  
-  Product was released from electronic or physical quarantine and 
distributed prior to determining whether the product was suitable for 
distribution;  
-  The distribution of a product prior to resolution of a discrepancy in 
manufacturing, such as testing, labeling or donor eligibility;  
-  The inappropriate distribution of unit with a positive test result.    
  The distribution of an outdated product;  
  Events associated with the storage or shipment of the product, for example: 
-  The product was not shipped at the appropriate temperature (e.g., the 
product was packed without ice for shipment);  
-  The product was not stored at the appropriate temperature prior to 
distribution; 
23   Contains Nonbinding Recommendations  
-  No documentation that the product was stored at the appropriate 
temperature, including reissuance of the product without a record of 
proper temperature maintenance; 
-  Visual inspection was not performed or documented prior to distribution.  
  Licensed establishments: You made a change from what is in your approved 
biologics license application (BLA) and you did not comply with the 
requirements of 21 CFR 601.12 (e.g., distributed products prior to approval of a 
supplement), if the change may affect the safety, purity or potency of the product.  
(see, Guidance for Industry: Changes to an Approved Application: Biological 
Products: Human Blood and Blood Components Intended for Transfusion or for 
Further Manufacture, December 2014 (Ref. 3)).  
  Donor was identified as a source of transfusion-transmitted infection such as, 
hepatitis B or C, HIV, malaria, babesiosis, West Nile virus.  
  Donor tested negative and products were distributed.  The donor returned for 
another donation and tested positive by testing under 21 CFR 610.40 for an RTTI 
described in 21 CFR 630.3(h), and for which lookback is conducted.6 
 
For transfusion services, reportable events may include the following: 
  Incorrect product or unit issued for a specific patient (unless the 
transfusion service notified the hospital staff that the product ordered was 
unavailable and that the transfusion service was providing a substitute):  
-  Special processing or testing requested, such as leukoreduced, 
irradiated, cytomegalovirus (CMV) negative, but product didnt meet 
specification  
-  Product issued that was designated for different patient  
-  Incorrect product type issued, such as Platelets instead of Fresh 
Frozen Plasma  
  Product with the improper ABO or Rh type was selected for a patient.  
  Visual check of product was not performed or not documented prior to 
distribution.  
  Product was received from a blood establishment, accepted into the 
transfusion services inventory and subsequently discovered to be 
hemolyzed after distribution. 
 
DO NOT REPORT:  
  Product was shipped to the incorrect facility.  
  Product is properly labeled but the shipping invoice differs from the 
actual shipment.  
                                                 
6 See 21 CFR 610.46 for HIV lookback requirements and 21 CFR 610.47 for HCV lookback requirements.  FDA 
has also issued guidance documents with recommendations relating to lookback procedures (e.g., quarantine and 
retrieval with subsequent consignee notification) for other RTTIs (see, e.g., Guidance for Industry, 
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis (May 2019)).  Additional guidance 
documents are available at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.     
24   Contains Nonbinding Recommendations  
  Blood establishment shipped an order to another blood establishment for a 
specific type of product, but did not fulfill the specific request, and the 
product was properly labeled and not labeled for a specific patient.  For 
example, an order for Red Blood Cells Irradiated was filled with a unit of 
Red Blood Cells that was properly labeled as Red Blood Cells.  
  Otherwise unsuitable product, such as an expired human leukocyte 
antigen (HLA) matched platelet, was issued through emergency release 
and documented appropriately (see 21 CFR 606.160(b)(3)(v)).  
  Frozen product (e.g., Fresh Frozen Plasma) container broke during 
thawing and the product was discarded.  
  Product broke or was damaged during shipment and the product was 
discarded.* 
  Licensed establishments:  You made a change in what was approved in 
your BLA to appear on your product container labels, and you did not 
submit the change for review in accordance with 21 CFR 601.12(f), 
provided the change does not affect the safety, purity or potency of the 
product (for example, you changed your legal name or added a doing 
business as secondary name on your labels).  
  A segment was found to be clotted or hemolyzed, but the product was 
subsequently evaluated for clots or hemolysis and found acceptable.  
  Small residual clots were found in the filter after product was completely 
transfused, unless you did not adequately evaluate the unit for clots prior 
to issuing unit for transfusion.  
  No documentation of instrument or reagent QC if there was data from 
another source that showed the instrument or reagent was acceptable, for 
example:  
-  No documentation of acceptable reagent storage temperature, but 
reagent QC was documented to be acceptable;  
-  Temperature was not documented on recording chart, but manual 
temperature readings that were documented are acceptable.  
  Recipient identified with transfusion-transmitted infection, but donor was 
ruled out as source of transfusion-transmitted infection and donor 
eligibility (e.g., screening, testing) was acceptable.   
 
*Broken or damaged products are rarely identified as system problems in 
manufacturing and are generally tied to an unusual event in shipment.  
 
   For transfusion services, non-reportable events may include:  
  Inappropriate administration practices by the hospital staff in transfusing 
the patient; for example:  
-  Hospital staff transfused the wrong patient;  
-  Hospital staff transfused the patient with the wrong product or unit;  
25   Contains Nonbinding Recommendations  
-  Hospital staff transfused the patient without using the appropriate 
filter.  
  Allogeneic product was distributed when an autologous product was 
available.  
  Product was distributed using an emergency protocol, provided it was 
labeled appropriately.  
 
 
   
26   Contains Nonbinding Recommendations  
V.  REFERENCES  
  
1.  Biological Products:  Reporting of Biological Product Deviations in Manufacturing; 
Final Rule (65 FR 66621, November 7, 2000).  Available at  
https://www.govinfo.gov/content/pkg/FR-2000-11-07/pdf/00-28133.pdf.  
  
2.  Guidance for Industry:  Biological Product Deviation Reporting for Licensed  
Manufacturers of Biological Products Other than Blood and Blood Components, October 
2006.  Available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/biological-product-deviation-reporting-licensed-manufacturers-biological-
products-other-blood-and.  
  
3.  Guidance for Industry:  Changes to an Approved Application:  Biological Products: 
Human Blood and Blood Components Intended for Transfusion or for Further 
Manufacture, December 2014.  Available at 
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulato
ryInformation/Guidances/Blood/UCM354668.pdf.   
  
 
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