Search results for Fda Warning Letters

FDA warns New York firm for failing to verify safety of imported foods

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...

FDA warns three importers for failing to verify safety of imported foods

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...

FDA cites three companies for failing to verify safety of a variety of imported products

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...

FDA warns four firms in California and Oregon over Listeria, HACCP and sanitation failures

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 u...

FDA warns three firms after finding rodents, bird droppings and allergen risks in food facilities

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...

FDA cites Ocean Group Inc. seafood facilities for Listeria, sanitation failures across four sites

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 u...

FDA warns airline caterer, Florida bakery after Listeria and allergen violations

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 u...

FDA warning letters are on the rise

-- OPINION --

FDA Warning Letters Are Rising and What It Signals for Food Manufacturers and Global Suppliers 

By Fabiola Negrón is the Director of Food Safety at Registrar Corp Key takeaways: Enforcement has matured: The FDA has moved past education and now issues warning letters quickly w...

Amid Flurry of FDA Warning Letters, Failure to Plan Is Prescription for Pain, Attorneys Say

"I hate to be rudimentary for those who've been in this business for a long time, but I often have clients that don't understand that FDA enforcement...is law enforcement," said at...

FDA warns of fines for misleading advertising

Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies

By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —

Medline hit with FDA warning letter over defective heart syringes, safety hazards

After Medline pulled off a massive $6.26 billion IPO late last year, the company now finds itself facing serious concerns being leveled by the FDA.

Medspas on Alert: The FDA Says You’re a Dispenser Too

Key Takeaways Medspas and other entities operating in the aesthetic space that dispense or administer prescription drugs should assess whether they have obligations as dispensers...

Feds warn telehealth companies about "illegal marketing" of compounded GLP-1s

The U.S. Food and Drug Administration is cracking down on telehealth companies for making “false and misleading” claims about compounded versions of popular weight loss drugs, GLP-...

FDA steps up enforcement actions on imported cheese, seafood, dried peppers and more

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

FDA issues warning after cookie company refuses to recall products

The FDA is warning consumers with milk, wheat, or tree nut allergies not to eat, and retailers not to serve or sell certain Imperial-brand cookies and candies manufactured by Imper...

Dietary Supplement Companies, Natural Medicine Group Sue FDA Over Health Claims

A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercia...

FDAs Warning Letter Suggests Growing Scrutiny of AI Overreliance

A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is exp...

Won’t Get Fooled Again: FDA Tells a Drug Company Don't Rely on AI

Key Takeaways - The Food & Drug Administration issued a Warning Letter citing a drug company for inappropriate use of AI in pharmaceutical manufacturing, marking what appears t...

FDA steps up import enforcement for illegal colors, pesticides and allergens

FDA increases enforcement of import rules for products with Salmonella, pesticides and heavy metals

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

FDA increases enforcement of import laws because of pesticides, unsafe additives

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

FDA Sends Notices to More Than 2,200 Sponsors Regarding Unpublished Clinical Trial Results

The U.S. Food and Drug Administration (FDA) announced on April 13, 2026, that it sent reminder letters to more than 2,200 drug, biologic, and medical device companies and researche...