---
kind: "section"
citation: "21 C.F.R. § 1271.320"
title: "21"
number: "1271.320"
heading: "Complaint file."
url: "https://uscodex.org/cfr/21/1271.320"
---

# §1271.320. Complaint file.

- (a) **Procedures.** You must establish and maintain procedures for the review, evaluation, and documentation of complaints as defined in [§ 1271.3(aa)](/cfr/21/1271.3.md?p=aa), relating to core current good tissue practice (CGTP) requirements, and the investigation of complaints as appropriate.
- (b) **Complaint file.** You must maintain a record of complaints that you receive in a file designated for complaints. The complaint file must contain sufficient information about each complaint for proper review and evaluation of the complaint (including the distinct identification code of the HCT/P that is the subject of the complaint) and for determining whether the complaint is an isolated event or represents a trend. You must make the complaint file available for review and copying upon request from FDA.
- (c) **Review and evaluation of complaints.** You must review and evaluate each complaint relating to core CGTP requirements to determine if the complaint is related to an HCT/P deviation or to an adverse reaction, and to determine if a report under [§ 1271.350](/cfr/21/1271.350.md) or another applicable regulation is required. As soon as practical, you must review, evaluate, and investigate each complaint that represents an event required to be reported to FDA, as described in [§ 1271.350](/cfr/21/1271.350.md). You must review and evaluate a complaint relating to core CGTP requirements that does not represent an event required to be reported to determine whether an investigation is necessary; an investigation may include referring a copy of the complaint to another establishment that performed manufacturing steps pertinent to the complaint. When no investigation is made, you must maintain a record that includes the reason no investigation was made, and the name of the individual(s) responsible for the decision not to investigate.

## Notes

### Source

Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.