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 ...

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On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood ...

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 ...

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

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 ...

Zydus Lifesciences continues to be under intense scrutiny from the FDA, which hit the Indian drugmaker’s production facility in Jarod with a warning letter. Earlier this year, Zydus was slammed within ...