Time to clean my desk

Message

gsabc · #1 Post by **gsabc** » Tue Dec 18, 2007 8:15 am

The piles have finally reached the stage where even I can't find things. Time to sort, file and reorganize. I shall return at a later time.

PlacentiaSoccerMom · #2 Post by **PlacentiaSoccerMom** » Tue Dec 18, 2007 8:16 am

Good for you for reorganizing!

peacock2121 · #3 Post by **peacock2121** » Tue Dec 18, 2007 9:42 am

Goodness.

I thought you got fired.

Whew!

Jeemie · #4 Post by **Jeemie** » Tue Dec 18, 2007 9:48 am

peacock2121 wrote:Goodness.

I thought you got fired.

Whew!

I thought the same thing- I read it as "Time to clean OUT my desk".

gsabc · #5 Post by **gsabc** » Tue Dec 18, 2007 12:20 pm

Sorry for the confusion. Just got handed my paycheck, so I guess I'm still here for a bit.

Besides desk cleaning, I've been fighting with the oddities of FDA regulations. We make medical devices. We are a contract manufacturer, meaning we make products for other companies, which design them. We have been registered as a device manufacturer since the company started. Because we don't actually distribute the products, but send them to our customers who then release them for sale, we are not required to be FDA-registered. The rules changed somewhere in there. The problem is that our customers, present and potential, ALWAYS ask for our registration number. And if we're not registered, does that mean we aren't subject to FDA inspections? If it does, that will not go over well with our customers.

I have been trying to re-register the company anyway, but the website won't recognize us as a currently registered company, even though I can pull up our registration from another page on the website. And the FDA no longer accepts paper registrations. Everything has gone electronic and become web-based. This bureaucrat can't get through to the bureaucracy.

My brain can't handle this right now. I will call them tomorrow to find out how to re-register, or else have them give me something to tell our customers. We just HAVE to be subject to inspections. The alternative is mind-boggling to me, not just for my company, but for medical devices made by contract manufacturers in general.

earendel · #6 Post by **earendel** » Tue Dec 18, 2007 12:27 pm

gsabc wrote:Sorry for the confusion. Just got handed my paycheck, so I guess I'm still here for a bit.

Besides desk cleaning, I've been fighting with the oddities of FDA regulations. We make medical devices. We are a contract manufacturer, meaning we make products for other companies, which design them. We have been registered as a device manufacturer since the company started. Because we don't actually distribute the products, but send them to our customers who then release them for sale, we are not required to be FDA-registered. The rules changed somewhere in there. The problem is that our customers, present and potential, ALWAYS ask for our registration number. And if we're not registered, does that mean we aren't subject to FDA inspections? If it does, that will not go over well with our customers.

I have been trying to re-register the company anyway, but the website won't recognize us as a currently registered company, even though I can pull up our registration from another page on the website. And the FDA no longer accepts paper registrations. Everything has gone electronic and become web-based. This bureaucrat can't get through to the bureaucracy.

My brain can't handle this right now. I will call them tomorrow to find out how to re-register, or else have them give me something to tell our customers. We just HAVE to be subject to inspections. The alternative is mind-boggling to me, not just for my company, but for medical devices made by contract manufacturers in general.

Good luck fighting the bureaucracy. My second son works a help desk for an AutoCADD company and got a call from a pharmaceutical company that was having problems installing some AutoCADD software. My son suggested several things to try, but every time the person on the phone said, "I can't do that because FDA regulations require me to notify them of any changes we make."