FDA Beginning to Tighten Enforcement Efforts

In line with last year’s announcement of a change to FDA’s enforcement policy, AFIA has recently learned that FDA’s Center for Veterinary Medicine (CVM) is closely watching compliance efforts for serious violations of the good manufacturing practices regulations for medicated feed (Title 21, C.F.R., Part 225). AFIA was told that the agency may seriously consider seizing feed products for the “right” potential case.

Traditionally, FDA has sought to remove violative products from the marketplace and hold “bad actors” accountable by seeking consent decrees from federal courts. In such a decree the court orders the firm to comply based on past violations. The court usually appoints a master to control drugs or other articles at the defendant’s operations. These efforts are fairly costly and resource-intensive and require FDA to constantly reinspect the firm’s facilities.

Violation of a consent decree can become quite serious with a judge holding the firm in contempt of court and ordering sanctions that might include incarceration or fines. 

However, FDA has stated it will pursue criminal sanctions against violators, especially the presidents of firms that seriously violate the law. Other sanctions could include seizure of products and civil sanctions. 

AFIA urges firms to review compliance programs and be vigilant and cooperative when inspected. Warning letters (so titled at the top of the letter) to firms, which normally go to the president or chief executive office, should be reviewed, actions taken and prompt replies made to the district office within the specified timeframes in the letter. 

AFIA has developed both a webcast and compliance guide to FDA inspections. To purchase the webcast, please click here. The inspection guide can be accessed here. 

Please contact AFIA vice presidents Richard Sellers at (703) 558-3569 rsellers@afia.org or Keith Epperson at (703) 558-3568 or kepperson@afia.org with compliance or inspection questions.