Guide for US FDA-Regulated Organizations
In such stringently controlled industries as pharmaceutical/biotechnical/medical device development, manufacturing, and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system. The following article shows three excerpts from some of the more common “observations” noted in Form 483 Letters during 2008-2009. None of the deviations excerpted here are unique, but all are avoidable. After the excerpts, the reader will find an outline of the best practices of a 483 response, including a 10-point checklist that should make that 15-day time limit more manageable, links for further research, and some ways to simplify and automate monitoring, alarming and reporting on FDA regulated environments.