GLOSSARYGlobal
Complaint
Any communication that alleges a deficiency in a released device or related service, such as its quality, safety, usability, or performance. A complaint can be written, electronic, or oral. Part 820 requires a manufacturer to keep complaint records.
Avoid This Mistake
A complaint about a possible failure to meet a specification needs a recorded review, evaluation, and investigation under 21 CFR 820.35(a). A similar earlier investigation can stand in only with a recorded justification.