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Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked with rooting out dangerous manufacturing practices.
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
On Wednesday, April 21, 2021, the Food and Drug Administration released a report saying the now-idle Emergent Biosciences factory where a key contractor hired to help make Johnson & Johnson’s ...
FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight Vandana Singh Wed, May 7, 2025, 2:54 PM4 min read ...
Federal regulators are grappling with a significant backlog of factory inspections for drug manufacturing, with many facilities not reviewed since before the pandemic. An analysis by The ...
Glenmark’s backlogged testing “was overdue by 3 months or longer for a large proportion of your samples,” the FDA wrote in ...
FDA also would retain authority over food imports inspection. It’s easy to be “in the know” about agriculture news from coast to coast! Sign up for a FREE month of Agri-Pulse news.
FDA’s food experts are grouped in different locations throughout the U.S. “As they close these different sites you’re just losing entire skillsets and areas of expertise,” Mayne said.
Pune: On the cusp of the annual palkhi procession's journey, the Food and Drug Administration (FDA) in Pune has stepped up vigilance at temporary food.
"For FDA to meet the inspection timeframes moving forward, it would need to inspect approximately 7,000 high-risk facilities each year. However, FDA inspected only about 58 percent of that amount ...
The nearly 8 million doses of J&J vaccine that had been used in the U.S. came from European sources. The Baltimore factory halted production late last week at the request of the FDA.
About one-third did not have the experience to conduct independent foreign inspections, the GAO found. Two FDA inspectors said the agency needs an additional 100 to 200 experienced investigators to do ...