Complaints and not the legal manufacturer?


Involved In Discussions
Trying to get more information on the extent needed for complaints received but we are not the legal manufacturer.

1. If we are not the legal manufacturer would I need to log these in my complaint system? Or can i just forward the information to the manufacturer?
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Quality Systems Program Manager
Agreeing with @indubioush, what role are you in the supply chain? Supplier of a component/material? Distributor? Importer? Health facility? Are you US-based?

Additionally, did the complaint allege an adverse event or death?

All these things can change how you manage the complaint.
21CFR803.18 (d)

(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.
(2) You must retain copies of the required device incident records for a period of 2 years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater. You must maintain copies of these records for this period even if you no longer distribute the device.
(3) You must maintain the device complaint files established under this section at your principal business establishment. If you are also a manufacturer, you may maintain the file at the same location as you maintain your complaint file under part 820 of this chapter. You must permit any authorized FDA employee, at all reasonable times, to access, to copy, and to verify the records required by this part.


Quality Systems Program Manager
Good info, indubioush.

Follow up question: is there any contractual agreement on complaint handling? I know, working at a CMO, that customer complaint handling can be a little confusing if you aren't the legal manufacturer. Generally there are provisions put in place upon initiation of an agreement between a manufacturer and distributor. It could be something as simple as just forwarding it to the registration holder for investigation (while maintaining your own complaint file), but it could also outline more responsibilities on your end. And, if you are the customer facing organization, you most likely have the privilege of dealing with the end user. Check your contract, just to be sure.


Trusted Information Resource
So seriously, if you are a distributor, you receive complaints and just sit on them, in case the FDA drops by? I also looked at
Sec. 803.10 , and it seems distributors are excluded from reporting requirements?

PS I hate the Q&A format used for these regulations. Just had to say that.


Involved In Discussions
That is what i am trying to figure out. we currently log the complaint in our system and forward the complaint to the legal manufacturer. Then it sits in our system as we do not investigate the complaint.

So do i just log and close out with rational the investigation will be done by the manufacturer?


Trusted Information Resource
Well, the way I read the regulations, you don't even have to report the complaint to the manufacturer.

Since I don't think the regulations make any sense, I'd fall back on the contractual agreement to work out something that does make sense, from the perspective of trying to minimize the number of devices on the market that are doing harm to patients and nobody knows it, because no one is following up.

I would forward the complaint to the manufacturer. It's their device, and it looks like the regulations don't require you to investigate. Since the manufacturer has distributors isolating them from those who use their devices, they will be inclined to forget about the users and instead investigate from a manufacturing perspective, which is to say, to try to find out if they had a bad lot, or something has gone amiss with their production process. I would cleverly try to con them into paying me to investigate on the user side. But that's just me, because I know how to investigate on the user side, while many/most distributors do not, I don't think. So most distributors would prefer to follow up with their customers as needed to support the manufacturer's investigation, at the manufacturer's request. Whether any manufacturers are likely to want this service enough to pay for it, I can't say.


Involved In Discussions
Agree we do not investigate a product not manufactured by us. I assume we will just log the complaint and close it with rationale of why we are not investigating. we hardly get any feedback from the manufacturer as to the investigation.
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