Offices of Regulatory Affairs and Criminal Investigation Kept Busy
ROCKVILLE, MD-The Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA) and Office of Criminal Investigation (OCI) reported record high numbers of recalls and detentions of potentially hazardous products, criminal convictions, and fines for the 1999 fiscal year. Contributing to the total 3,736 recalls were 1,295 non-compliant blood and blood products and 1,263 medical devices. The FDA detained 41,474 import shipments, almost half of which contained fresh produce and food deemed unsafe or in violation of FDA standards. The ORA conducted 15,161 facility inspections and consequently issued over 7,000 noncompliance lists and 900 warning letters. In addition, eight injunctions were conducted one of which resulted in a record payment of $100 million for a civil violation of public health laws. Not to be outdone, the OCI won 211 court convictions breaking all records set since its inception seven years ago.
Hiding in Plain Sight: The Most Harmful and Costly Hospital-Acquired Infection
February 5th 2025Nonventilator hospital-acquired pneumonia (NV-HAP) is a deadly, overlooked infection impacting patient outcomes. With new diagnostic tools and prevention strategies, hospitals must prioritize oral hygiene to reduce risk.
Gag Order Puts Public Health at Risk, APIC Urges Immediate Action
February 4th 2025APIC warns that the HHS gag order on CDC communications endangers public health, delaying critical infection updates and weakening outbreak response amid rising tuberculosis, avian flu, Ebola, and measles threats.