A Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a ...
Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls. The letter comes in ...
The FDA warned companies selling chest binders to register their products as medical devices. Here's how they're responding.
The U.S. FDA has issued a warning letter to Hims & Hers Health (NYSE:HIMS) over its marketing of compounded semaglutide, the weight loss drug marketed under the brand name Wegovy by Novo Nordisk (NVO) ...
The US Food and Drug Administration on Tuesday released approximately 100 warning letters it had sent to drug companies on September 9, alleging that the companies made false or misleading claims on ...
In a Nov. 17 warning letter the Food and Drug Administration outlined problems at Bedner Growers Inc. of Boynton Beach, FL, ...
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism ...
In September, FDA issued warning letters at three Philips manufacturing facilities across the U.S. and Europe, noting shortcomings in quality control. Impacted facilities include two ultrasound ...
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