Is it a requirement to notify my customer if I receive a 483 from the FDA?

RCW

Quite Involved in Discussions
I am a contract manufacturer of medical devices.

Is it a requirement to notify my customer if I receive a 483 from the FDA?
If so, if the 483 pertains to one customer's medical device but not another, do I need to notify that other customer?

Are there any good links that would address this?
 

Mark Meer

Trusted Information Resource
I agree with Ajit. ...But if this is not clear in a formal agreement, though not a requirement elsewhere, as a customer I would probably appreciate being kept in the loop.

FDA 483 observations are not uncommon, and shouldn't be a deal-breaker, provided you've got plans for addressing them (or justification not to).

As you draft a response to the FDA (which you are presumably doing), perhaps also send the response to the customer. That way, the customer is aware of the observations, and that you are being diligent in addressing them.

Ultimately, keep your customer-relationship in mind, and do what is prudent. If the observations are minor and quickly fixed, maybe don't bother. If the observations could affect the product you are (and have been) delivering, then the customer would probably appreciate knowing...
 
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L

lfrost

I agree with what both above have said. You must remember that with the FDA whenever they inspect, they always leave a 483. They will always find something to list on it. Your customer should realize this and that you will make the necessary corrections to your quality system.

FWIW: We just had our FDA Inspection and the inspector left us with only three observations on the 483. All three were minor, two were about the Training we have and didn't document, the other was concerning three resolved corrective actions that didn't list the root cause.

So I really don't think you nor your customer should really worry about the 483 observations. Just hope you do not receive a Written Warning Letter which becomes public record!
 
M

MIREGMGR

If I'm your customer, I'm the ultimate party at risk. FDA could shut down your manufacturing of my products, or require a recall of my products. The latter in particular could damage my market reputation and cost me a ton of money.

If I'm your customer and you don't tell me immediately, either you've violated my quality agreement with you, which should require immediate communications of such a situation; or I've done an incompetent job of contractually defining our relationship, which is a regulatory obligation of mine.

If you don't tell me immediately, I won't know that my technical and quality supervision of your manufacturing has been incompetent, in that it didn't spot whatever the FDA inspector cited you for.

Until you tell me, I won't know that I'm exposed to issuance of a Warning Letter to me, even though it was you that was inspected, for fundamental 21CFR 820 supplier control violations.

Beyond that, if you don't tell me immediately, you've shown me that we have a relationship in which you think it's desirable or necessary to hide information from me regarding quality issues (whatever was cited on the 483) and regulatory issues (the fact of the inspection and 483 issuance).

If you tell me immediately, I might keep you as a supplier, depending on the circumstances. If you don't, you're gone as soon as I can make another arrangement.
 

RCW

Quite Involved in Discussions
Currently I do not have any 483s issued against my company. In fact, during the last FDA audit about 3 years ago, no 483s were issued at all. :)

I had a medical device customer inquire about not addressing flowing 483 results back to them. After pulling out their quality agreement, they require this. I pulled quality agreements out from two other medical device customers and they did not require the results.

My quest was to determine if there was a standard flowing down this requirement to me. From the good information that has been posted here, it appears to be coming solely from the quality agreement.

I've only had a couple of 483 issued and they were general in nature. It was my concern if the 483 ever included product specific information that a different customer should not have access to (nondisclosure violation). If they are kept in a general, systemic format, then the 483 can and should be freely shared with all my customers.
 

Ronen E

Problem Solver
Moderator
Currently I do not have any 483s issued against my company. In fact, during the last FDA audit about 3 years ago, no 483s were issued at all. :)

I had a medical device customer inquire about not addressing flowing 483 results back to them. After pulling out their quality agreement, they require this. I pulled quality agreements out from two other medical device customers and they did not require the results.

My quest was to determine if there was a standard flowing down this requirement to me. From the good information that has been posted here, it appears to be coming solely from the quality agreement.

I've only had a couple of 483 issued and they were general in nature. It was my concern if the 483 ever included product specific information that a different customer should not have access to (nondisclosure violation). If they are kept in a general, systemic format, then the 483 can and should be freely shared with all my customers.

If there are confidentiality issues you could always mask out the client-specific info, and explain that when you communicate the 483. Maybe even worth mentioning in the quality agreement upfront, to avoid surprises and unnecessary debates down the track.
 
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