The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, according to reports.
Tag Archive for: Inspections
India has found violations related to manufacturing and laboratory practices at drugmaker Riemann Labs, whose cough syrup was linked to the deaths of children in Cameroon, a government health official told Reuters on Wednesday.
India’s pharmaceuticals regulator has begun inspecting some drug factories across the country, the health ministry said on Tuesday, as it tries to ensure high standards after an Indian company’s cough and cold syrups were linked to deaths in Gambia.
Wuxi Biologics, a Chinese company that makes ingredients for AstraZeneca’s COVID-19 vaccine, may be a step closer to being taken off a U.S. trade list that it landed on five months ago, wiping HK$77 billion ($9.9 billion) off its market value at the time.
A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.
Lawmakers grilled U.S. Food and Drug Administration officials on Wednesday over what they saw as a lack of urgency in the agency’s response to complaints about possible baby formula contamination at a now shuttered Abbott Laboratories plant that led to severe nationwide shortages.
