Warning Letter adressed to owner/operator or facility?

[Luwak]

Our facility is registered with the FDA since last year. We share a production site (with separate buildings) and postal address with another FDA registered company owned partly by the same (legal) owner. Since the FDA does not allow more than one owner/operator on the same address, we have registered our facility under the same owner/operator.

Our biggest customer now has concerns that noncompliance by the other company can result in difficulties with our products if they receive a warning letter from the FDA.

I have tried to find out whether FDA issues warning letters at the level of facility or owner/operator, but so far this remains unclear to me. When I look at warning letters on the FDA website they are addressed to a contact person and no registration number of either owner/operator or facility is mentioned.

 

[Ronen E]

Our facility is registered with the FDA since last year. We share a production site (with separate buildings) and postal address with another FDA registered company owned partly by the same (legal) owner. Since the FDA does not allow more than one owner/operator on the same address, we have registered our facility under the same owner/operator.

Our biggest customer now has concerns that noncompliance by the other company can result in difficulties with our products if they receive a warning letter from the FDA.

I have tried to find out whether FDA issues warning letters at the level of facility or owner/operator, but so far this remains unclear to me. When I look at warning letters on the FDA website they are addressed to a contact person and no registration number of either owner/operator or facility is mentioned.

Hi,

As far as I can recall, all medical device warning letters I've seen begin with a reference to specific products that are medical devices. Hence it's very clear what manufacturer they relate to. My current feeling is that there's no real reason for such concern.

Cheers,
Ronen.