Watchdog groups report that while the number of regulated facilities has increased, the volume of inspections has ...

FDA inspectors found a live spider and dead cricket in a facility that was compounding weight loss drugs for Hims & Hers.

Real-Time Compliance Tracking, FDA Inspection Data, and Proactive Risk Management for Life Sciences Quality Teams ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

Some staff members say they are frustrated with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The official in charge of federal food and drug safety ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The Food and Drug Administration is expanding the use of unannounced inspections at foreign facilities that produce foods and medicines, building on a pilot program already used in India and China.