Complaint
Complaint means any written, oral, or electronic communication about a distributed HCT/P that alleges:
(1) That an HCT/P has transmitted or may have transmitted a communicable disease to the recipient of the HCT/P; or
(2) Any other problem with an HCT/P relating to the potential for transmission of communicable disease, such as the failure to comply with current good tissue practice.
Source
21 CFR § 1271.3
Scoping language
The following definitions apply only to this part: