Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre CGM production.

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 Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

NEW YORK — The US Food and Drug Administration has issued warning letters to four direct-to-consumer health testing companies for selling unauthorized blood collection kits for HIV diagnosis.

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or ...

The US Food and Drug Administration (FDA) has followed up on its promise to clampdown on misleading and deceptive drug advertisements in the US, with the agency publishing a large batch of warning ...

The U.S. Food and Drug Administration (FDA) sent over 50 warning letters to GLP-1 drug compounders and manufacturers in September 2025. The agency warned the companies that their statements that ...

The FDA sent letters to 3 formula companies with quality control concerns. The FDA has sent warning letters to three formula companies, red-flagging concerns about serious quality control issues at ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities. The warning ...