Customer is FDA Certified - Must we also be FDA Certified?

[catfish4862]

We provide testing services to an FDA Certified company. We do not manufacture anything for sale to the general public. (We test many things, for example the absorbant capacity of tampons.....to the liquid repellancy of hospital gowns and masks and report these results to the Customer).

We've never claimed to be FDA compliant, much less certified. But I'm wondering if the FDA came in to audit our Customer, could/would they come and audit our testing facility? And could/would we be written up for violations?

Thank you for your help.
I need to visit this site more often.

[Scott Catron]

I'm not a device expert, but my guess is that your customer has to audit your operations as it relates to the testing you do for them, but that your company wouldn't have to register with the FDA or be subject to FDA inspections.

[Stijloor]

Originally Posted by catfish4862

Thank you for your help.
I need to visit this site more often.

Hello catfish,

Please do, help out if you wish, and by all means; tell others!

Stijloor.

[AndyN]

Originally Posted by catfish4862

We provide testing services to an FDA Certified company. We do not manufacture anything for sale to the general public. (We test many things, for example the absorbant capacity of tampons.....to the liquid repellancy of hospital gowns and masks and report these results to the Customer).

We've never claimed to be FDA compliant, much less certified. But I'm wondering if the FDA came in to audit our Customer, could/would they come and audit our testing facility? And could/would we be written up for violations?

Thank you for your help.
I need to visit this site more often.

Since you are providing testing service to a customer, it's their responsibility to ensure that you are capable of meeting their requirements and that any FDA requirements are passed on where applicable.

However, as a testing lab, you might want to consider becoming accredited to ISO/IEC 17025:2005 (and you could take a look at ISO 15189:2003, - I know, it's for clinical labs.)

It's unlikely that the FDA would arrive and audit you to 820CFRwhatever. But, realistically, without some formalized management system in place, it puts your customer at risk and, therefore, your lab. It may not be significant, so why not perform a risk assessment................?

[Ajit Basrur]

I moved the thread to this section which addresses FDA issues.

Btw, all the responses are very good. No FDA certification is required for your laboratory.

[Scott Catron]

I think the point should be made that the FDA doesn't 'certify' a company. It approves drugs and devices, but it only inspects companies, and those inspections are only a snapshot of the operations - all their reports stipulate this, so that folks can't go around crowing about how the FDA has 'certified' their quality system.

Companies register with the FDA each year, but that's just so the FDA can keep track of who's doing what - it's not an approval.