Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

November 15, 2019
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The Importance of Effective Quality Management in Complying with the European Union's GMP Standards
The Importance of Effective Quality Management in Complying with the European Union's GMP Standards

This white paper gives an overview of the European Union’s Good Manufacturing Practice standards, including...

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Managing Change Control to Comply with FDA and EU Regulations
Managing Change Control to Comply with FDA and EU Regulations

Uncontrolled changes to a pharmaceutical or medical device product have the potential to affect public heal...