As part of its enforcement activities, the U.S. Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners generally have 15 working days to respond to FDA warning letters. Warning letters often are not issued until companies have been given months or years to correct problems. Portions of the letters are commonly redacted from public view.
The U.S. Food and Drug Administration has issued a warning letter to Flax & More Corporation in Cutler Bay, FL, citing significant current Good Manufacturing Practice (CGMP) violations that the agency said caused the company's dietary supplements to be adulterated under federal law.