21 CFR 606.170: Adverse reaction file
Requires blood facilities to record and thoroughly investigate adverse reactions from collection or transfusion, keep written reports with the unit's records, share them with the manufacturer when the product is at fault, and report fatalities to CBER promptly, with a written report within 7 days.
Part 606, Current Good Manufacturing Practice for Blood and Blood Components · Subpart I, Records and Reports
How FDA words it
The opening lines investigators use most when they cite 606.170, from the 483s we hold.
A thorough investigation of each reported adverse reaction was not made.Most used
Recent 483s citing 606.170
- CSL Plasma Inc. · —Failure to maintain records of transfusion reaction reports and complaints,… Aug 7, 2025
- ImpactLife · Urbana, IllinoisWritten reports of investigations of adverse reactions, including conclusions and… Jul 3, 2025
- American Red Cross Greater Alleghenies Regio · Johnstown, PennsylvaniaA thorough investigation of each reported adverse reaction was not made… Sep 24, 2010
- American National Red Cross · Tucson, ArizonaSep 15, 2010
- American National Red Cross Heart of America Region · Peoria, IllinoisA thorough investigation ofeach reported adverse reaction was not made… Aug 18, 2010
The regulation text
§ 606.170 Adverse reaction file.
(a)Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written report of the investigation of adverse reactions, including conclusions and followup, shall be prepared and maintained as part of the record for that lot or unit of final product by the collecting or transfusing facility. When it is determined that the product was at fault in causing a transfusion reaction, copies of all such written reports shall be forwarded to and maintained by the manufacturer or collecting facility.
(b)When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, CBER, must be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible. A written report of the investigation must be submitted to the Director, Office of Compliance and Biologics Quality, CBER, by mail, facsimile, or electronically transmitted mail (for mailing address, see § 600.2(a) of this chapter), within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction.
[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 50 FR 35471, Aug. 30, 1985; 55 FR 11014, Mar. 26, 1990; 64 FR 45371, Aug. 19, 1999; 67 FR 9586, Mar. 4, 2002; 77 FR 18, Jan. 3, 2012; 80 FR 18092, Apr. 3, 2015]
Questions
What does 21 CFR 606.170 require?
Requires blood facilities to record and thoroughly investigate adverse reactions from collection or transfusion, keep written reports with the unit's records, share them with the manufacturer when the product is at fault, and report fatalities to CBER promptly, with a written report within 7 days.
How do FDA investigators word a 606.170 observation?
The most common opening is: “A thorough investigation of each reported adverse reaction was not made.”
Which sections are cited alongside 606.170?
In the same 483s, investigators most often also cite 606.100 (Standard operating procedures), 606.20 (Personnel), 211.100 (Written procedures; deviations), 606.160 (Records).