Is there a requirement in 21 CFR 820 that states the organization documenting complaints must report to a Quality organization?

[PRFire]

All I can find in 820.198 is: Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

21 CFR 211.198.a states: Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with § 211.192.

Mind you, 211 only requires that a quality organization review complaints in the event of possible failure of a drug product to meet any of its specifications, but does not require a formally designated unit to handle the complaints.

 

[yodon]

FDA doesn't impose any kind of organizational structure.

 

[Nichole F]

If you look further in 21 CFR §211 it states the responsibilities of the Quality Unit. It doesn't explicitly state they handle complaints but it does say they are responsible for ensuring production record errors are investigated. Part 211 relates to drug manufacturing though so if you are manufacturing medical devices, as long as you have a formally designated complaint handling unit, you meet the requirements.

Keep in mind, FDA is integrating ISO 13485:2016 by reference, with enforcement starting February 2026, so you'll want to consider ISO 13485:2016 8.2.2 which just states you need to designate responsibility for complaint handling.