[reed13k]

On the Tylenol “takeover”. This was standard Consent Decree type of activity. I’ve been involved with a few of these and while this one was extreme in requiring all finished goods stock to be destroyed, the FDA didn’t directly manage the plants...they would never want to do that...too much liability on the govt then. They don’t even stick permanent agents into the plants like the USDA and FAA (sometimes for FAA like engine plants) require.

They just forced them, as with most CDs, to ‘use an independent safety expert to inspect the plants for violation corrections’ and jump through a number of other hopes to get out from under the CD.

Again standard practice for non-compliance to regulations ... I’ve 24 years in the device biz.

[Steve Van Doorn]

said, "Tylenol “takeover” of production (was a) .... standard practice for non-compliance to regulations"

thank you.

I understand do you know of other "takeovers" similar to this?
I would like to see how a large event like that doesn't get noticed.

[bitt]

THANKS for a learned response... never knew that