[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.320]

[Page 737-738]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.320  Complaint file.

    (a) Procedures. You must establish and maintain procedures for the 
review, evaluation, and documentation of complaints as defined in 
Sec. 1271.3(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 a adverse 
reaction, and to determine if a report under Sec. 1271.350 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 Sec. 1271.350. 
You must review and evaluate a complaint relating to

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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.