21 CFR 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 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 Center for Biologics Evaluation and Research (CBER), either in paper or electronic format.

(1)If you make a paper filing, send the completed form to the CBER Document Control Center (see mailing address in § 600.2(a) of this chapter), and identify on the envelope that a BPDR (biological product deviation report) is enclosed; or

(2)If you make an electronic filing, send the completed Form FDA3486 electronically using CBER's electronic Web-based application.

(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; 80 FR 18092, Apr. 3, 2015]