In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...
WASHINGTON -- Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the covid-19 pandemic upended factory ...
FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...
WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...
After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...
The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned ...
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...
In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing. The Food and Drug ...
Amid concerns about FDA’s capacity to meet safety mandates following the departure of 3,500 employee since January, the agency signals a new direction for inspections and ability to do more with less ...
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal ...
In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...