Notice library

FDA-regulated products

6 notice types from this area, each with its deadline, response options, and sources.

• Compounded GLP-1 FDA Warning Letter Response

  The FDA issued more than 55 warning letters to online sellers of compounded GLP-1 medications on September 16, 2025; 30 more warning letters to telehealth companies specifically over...

• FDA Form 483 Observation Response Navigator (Food/Supplement)

  The FDA conducts approximately 15,000–20,000 facility inspections per year across all regulated product categories. For food, dietary supplement, and nutraceutical facilities, the FDA...

• FDA Import Alert / DWPE Removal Petition

  FDA's Detention Without Physical Examination (DWPE) system places imported products on automatic detention at US ports once an import alert is issued. FDA issues import alerts when it has...

• FDA Medical Device Form 483 Observation Response

  FDA medical device facility inspections result in Form 483 observations at a significant rate. FDA issued 600–900 device facility Form 483s annually in recent years, with small...

• FDA Warning Letter Response

  The FDA issues approximately 400-600 Warning Letters per year across all product categories (foods, dietary supplements, drugs, medical devices, cosmetics, tobacco). In 2025, the FDA issued...

• FDA Warning Letter Response Navigator for Small Food, Supplement, and Cosmetic Companies

  FDA issues approximately 400–800 Warning Letters per year across food, dietary supplement, and cosmetics industries. Warning Letters are immediately posted on FDA.gov and are searchable by...

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