• Article Index

• Knowledgebase Index

• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

What enforcement or administrative actions can the FDA take if a manufacturer is in violation of their laws?

There are several avenues the FDA can take.  For most serious issues a Warning letter which requires manufacturers to respond within 15 days is drafted.   If there is unreasonable risk of substantial harm to public health they can also send notification out to users or the public. 

For foreign manufacturers your product(s) can also be restricted from entering the US.