The auditors are coming! The auditors are coming!
Posted: Thu Nov 13, 2008 2:50 pm
Luckily, not to my site.
I work at a contract manufacturing organization (CMO) for drugs and medical devices. The boss got a call from the FDA this afternoon about some confusion over our registrations. In talking with them, he actually managed to find out that they intended to visit. Although we have made both drugs and devices at my site, we no longer do drugs here (so to speak), and gave back our drug registration last year. All our audits at this site, though, have been for the drug regulations. We are due for one, but hoped to move before they came.
Our other site is where we do all our drug manufacturing now. They do have both drug and device registrations, but went through a name change at the start of last year which seems to have confused the FDA. That site has not yet had the honor of an FDA visit. Now they will.
This is not entirely a bad thing. One, this particular inspector has been to our facility before, though not to the new site, and found no observations. The quality systems are very similar. Two, we have been expecting the FDA at that site sometime soon, because one of our customers recently filed a submission for one of the products we make for them. Three, the boss was told that they intend to schedule two days for the audit, much less than we would expect for a pre-approval audit (for the submitted drug). And lastly, it is VERY good to say you've been successfully inspected by the FDA. It improves how you're viewed by prospective clients by an order of magnitude, at least.
I have been scanning and e-mailing old FDA reports, copies of our registrations, and anything else we can think of to the other site. I will be support for their audit from here, since all our earlier files reside in my office in my care. I am only ten minutes from there, should I need to answer questions directly.
One oddity about device registration. As a CMO which neither owns its own manufactured products nor distributes them for others, we are not required to be registered with the FDA at all. Potential customers and their auditors always ask about it, though, and I can't imagine that anyone would do business with us if we weren't.
The boss is nervous, and understandably so. It's his business, after all. I'm not. I have full confidence in our systems. They may find something, but I expect that if they do, it will be minor and easily fixed, possibly even before they leave. I'll keep you informed.
I work at a contract manufacturing organization (CMO) for drugs and medical devices. The boss got a call from the FDA this afternoon about some confusion over our registrations. In talking with them, he actually managed to find out that they intended to visit. Although we have made both drugs and devices at my site, we no longer do drugs here (so to speak), and gave back our drug registration last year. All our audits at this site, though, have been for the drug regulations. We are due for one, but hoped to move before they came.
Our other site is where we do all our drug manufacturing now. They do have both drug and device registrations, but went through a name change at the start of last year which seems to have confused the FDA. That site has not yet had the honor of an FDA visit. Now they will.
This is not entirely a bad thing. One, this particular inspector has been to our facility before, though not to the new site, and found no observations. The quality systems are very similar. Two, we have been expecting the FDA at that site sometime soon, because one of our customers recently filed a submission for one of the products we make for them. Three, the boss was told that they intend to schedule two days for the audit, much less than we would expect for a pre-approval audit (for the submitted drug). And lastly, it is VERY good to say you've been successfully inspected by the FDA. It improves how you're viewed by prospective clients by an order of magnitude, at least.
I have been scanning and e-mailing old FDA reports, copies of our registrations, and anything else we can think of to the other site. I will be support for their audit from here, since all our earlier files reside in my office in my care. I am only ten minutes from there, should I need to answer questions directly.
One oddity about device registration. As a CMO which neither owns its own manufactured products nor distributes them for others, we are not required to be registered with the FDA at all. Potential customers and their auditors always ask about it, though, and I can't imagine that anyone would do business with us if we weren't.
The boss is nervous, and understandably so. It's his business, after all. I'm not. I have full confidence in our systems. They may find something, but I expect that if they do, it will be minor and easily fixed, possibly even before they leave. I'll keep you informed.
)