4 03, 2016

7 Resources for Avoiding Form FDA 483s

By | 2017-11-06T03:57:33+00:00 March 4th, 2016|cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483|

As we’ve written extensively about the infamous Form FDA 483 here at FDAzilla, we’ve decided to make it easier for you.  Here, we’ve created a centralized list of the 7 best resources to go from Joe to Pro on understanding Form FDA 483s. […]

18 01, 2011

Tales from the Front: With the FDA in Costa Rica

By | 2017-11-06T03:55:34+00:00 January 18th, 2011|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspection Stories, FDA Inspections, Form FDA 483|

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 [...]