As we've written extensively about the infamous FDA 483 here at FDAzilla, we've decided to make it easier for you. Here, we've created a centralized list of the 8 best resources to go from Joe to Pro on understanding FDA 483s.
The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica. I had been sent there from the US to help a sister company with a pending inspection. I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order for the FDA inspector and [...]