FDA 483 & Warning Letter Response & Planning — DOs and DON’Ts

Jack Garvey |

If you are reading this now, you are probably in the middle of an enforcement crisis.   Responding to an FDA-483, Warning Letter, or in some cases, a product seizure or injunction can be one of the most important,... Read more

Pharmaceutical Company Subject of DOJ Sting, Story, Page 7

Jack Garvey |

Byline 1/19/2010, Legal Times DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal, compliance or risk-management leadership role inside an FDA-regulated company, and unless you’ve been... Read more

Audits, Assessments & Corporate Compliance Investigations

Jack Garvey |

Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready for any and all types of review by the FDA, Department of Justice... Read more