Return to blog

All "483" articles

Compliance
• August 20, 2019

Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?

In 2018, the FDA issued 124 fewer 483 observation letters to medical device companies than they did the previous year. In 2017, there were a total of ...
483
• October 11, 2016

What should I expect when the FDA comes knocking?

Complying with FDA, ISO and other regulatory guidelines protects individuals when they engage with health care products, but it demands a great deal ...