Author Archives: Morris Sherwood

Dinner in Costa Rica with an FDA inspector (and his wife)

TAXIDuring weekends in August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s a memorable story of an inspection in Costa Rica.

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. Continue reading

Tales from the Front: With the FDA in Costa Rica

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 his wife (did I mention he brought his wife with him?) to meet the President of the Costa Rica company. With any luck, it would help the upcoming inspection go smoothly. Continue reading