Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact | Site Map

FDA Law Enforcement in FY 1999

The FDA just released their enforcement numbers for FY 1999. Believe it or not, the FDA has achieved several new law enforcement landmarks in the past fiscal year. The FDA’s Office of Regulatory Affairs (ORA) and Office of Criminal Investigations (OCI) reported an all-time-high number of recalls and detentions of potentially hazardous products; carried out an unprecedented total of arrests and criminal convictions; and saw the successful conclusion of court cases resulting in record FDA-requested payments in history.

Some of these landmarks include:

• 1,295 recalls (nearly 1/3 of the 3,736 recall) involved non-compliant blood and blood products
• 41,474 import shipments of food and medical devices were detained
• nation wide, 1,002 consumer safety officers and investigators conducted 15,161 inspections of facilities producing, warehousing, or distributing food and health care products.
• 7,303 FDA 483s were issued
• 900 Warning Letters were sent
• 25 Seizures
• 8 Injunctions

One FDA injunction, based on repeated findings of non-compliance in such critical areas as process validation and production and process control, resulted in consent degree in which a firm agreed to stop manufacturing and distributing many of its products until it corrects in manufacturing problems. The firm also agreed to pay $100 million to the U.S. Treasury, the highest sum ever paid by an FDA-regulated company for a civil violation of public health laws.

OCI last fiscal year arrested 373 suspected violators of public health laws and won 211 court convictions, the highest total since the office was created seven years ago.

For more information on the FDA’s Law Enforcement report visit the FDA website are www.fda.gov or contact info@mdiconsultants.com.

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map