[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.171]

[Page 58-59]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
 
                      Subpart I_Records and Reports
 
Sec.  606.171  Reporting of product deviations by licensed manufacturers, 

unlicensed registered blood establishments, and transfusion services.

    (a) Who must report under this section? You, a licensed manufacturer 
of blood and blood components, including Source Plasma; an unlicensed 
registered blood establishment; or a transfusion service who had control 
over the product when the deviation occurred, must report under this 
section. If you arrange for another person to perform a manufacturing, 
holding, or distribution step, while the product is in your control, 
that step is performed under your control. You must establish, maintain, 
and follow a procedure for receiving information from that person

[[Page 59]]

on all deviations, complaints, and adverse events concerning the 
affected product.
    (b) What do I report under this section? 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 current good manufacturing practice, 
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 another facility under contract with 
you; and
    (3) Involves distributed blood or blood components.
    (c) When do I report under this section? You should report a 
biological product deviation as soon as possible but you must report at 
a date not to exceed 45-calendar days from the date 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.
    (d) How do I report under this section? You must report on Form FDA-
3486.
    (e) Where do I report under this section? You must send the 
completed Form FDA-3486 to the Director, Office of Compliance and 
Biologics Quality (HFM-600) (see mailing addresses in Sec.  600.2 of 
this chapter) by either a paper or electronic filing:
    (1) If you make a paper filing, you should identify on the envelope 
that a BPDR (biological product deviation report) is enclosed; or
    (2) If you make an electronic filing, you may submit the completed 
Form FDA-3486 electronically through CBER's website at www.fda.gov/cber.
    (f) How does this regulation affect other FDA regulations? This part 
supplements and does not supersede other provisions of the regulations 
in this chapter. All biological product deviations, whether or not they 
are required to be reported under this section, should be investigated 
in accordance with the applicable provisions of parts 211, 606, and 820 
of this chapter.

[65 FR 66635, Nov. 7, 2000, as amended at 70 FR 14984, Mar. 24, 2005]