Requirements for Complaint Files - Distributed Goods

A

AJump

Registered
I am having a hard time finding the requirements for complaint records for complaints received on products which our company distributes but which are also domestically manufactured. I'm not an importer or manufacturer, but I want to know what I'm required to have documented in these complaint files.

Where can I find this in the regs?
 
Al Rosen

Al Rosen

Leader
Super Moderator
AJump said:
I am having a hard time finding the requirements for complaint records for complaints received on products which our company distributes but which are also domestically manufactured. I'm not an importer or manufacturer, but I want to know what I'm required to have documented in these complaint files.

Where can I find this in the regs?
Click to expand...
What regs are you referring to? What types of products? If they are medical devices it's addressed in 21 CFR 820.198
 
A

AJump

Registered
820.198 has outlined requirements for when you are the manufacturer. We are just distributing class II device manufactured by an OEM. I assume the requirements are different but I can't find it outlined anywhere.
 
I

indubioush

Ah ha!
US FDA, yes?

Sec. 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?
....
(d)(1) If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, electronic, or oral communication, either received or generated by you, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness, or performance of a device. You must also maintain information about your evaluation of the allegations, if any, in the incident record. You must clearly identify the records as device incident records and file these records by device name. You may maintain these records in written or electronic format. You must back up any file maintained in electronic format.

CFR - Code of Federal Regulations Title 21
 
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