Do I need a letter to file?

JB0424

Starting to get Involved
#1
Recently, the company I work for received some complaints for a product. Through the investigation, it was found that a particular component could fail.
The company's response was to do a voluntary recall, and add a performance specification that was not previously identified. The product is now inspected to make certain the component meets the newly identified specification.

The product itself is not changed.

There's no new safety or performance issues associated with the product change itself.

Since this is associated with a voluntary recall, should we do a letter to file?
 
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John Broomfield

Leader
Super Moderator
#2
Recently, the company I work for received some complaints for a product. Through the investigation, it was found that a particular component could fail.
The company's response was to do a voluntary recall, and add a performance specification that was not previously identified. The product is now inspected to make certain the component meets the newly identified specification.

The product itself is not changed.

There's no new safety or performance issues associated with the product change itself.

Since this is associated with a voluntary recall, should we do a letter to file?
JB,

How about filing your corrective action request that describes the nature of the nonconformity (failure to fulfill customer requirements) and the changes made to your management system to remove the root causes of the customer complaint?

This CAR will also record the recall, the investigation to determine the root causes or refer to such records.

It will also refer to the results of your updated risk assessment and, when closed, provide evidence of verification that the actual root causes had been determined and removed from your system.

John
 
#4
According to 21CFR806, section 806.10, the important question to ask here would be,

Was the removal of a device initiated by manufacturer or importer initiated:

(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health?

If the answer of any of those questions is Yes, you need to report it to FDA. Check 806.10 (c) for further detail on report requirement.

If you determine that you do not need to report it to FDA, then according to 806.20 you would need to have a record (basically a CAR, justification for not reporting it to FDA and some additional details). Check 806.20 (b) for further detail on report requirement.
 
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