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As part of its enforcement efforts, the U.S. Food and Drug Administration (FDA) sends warning letters to agencies under its jurisdiction. Some letters are not posted publicly until weeks or months after they are sent. Business owners typically have 15 business days to respond to an FDA warning letter. Warning letters are often not issued until the business has been given months or years to correct the problem. Portions of the letter are usually redacted publicly.
The U.S. Food and Drug Administration (FDA) issued a warning letter to Flax & More Corporation of Cutler Bay, Florida, citing serious CGMP violations that caused the company’s dietary supplements to be classified as adulterated under federal law.
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