As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Sprout Pharmaceuticals failed to include drug risk information in a promotional social media post, the FDA said in a warning ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...

The warning letter followed an FDA inspection last year of Dexcom’s facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510 ...

The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and identified concerns in manufacturing processes and quality management.

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

Elanco Animal Health (NYSE:ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug Zenrelia. In the letter, the FDA said that an agency review of ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...