Named company: American Behavioral Research Institute, LLC
We acknowledge that this finding was not included on the Form FDA 483 you received, and therefore your written response does not directly address this violation as discussed in this letter. These efficacy…
Named company: Health Fixer
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market…
Named company: My Life Inc
Undeclared milk allergen
Named company: GNC Holdings LLC
Undeclared Fish allergen (parvalbumin).
Named company: M.O.M. Enterprises, LLC
Based on inspectional findings and a review of your product labels collected during the inspection, as well as a review of your firm’s website, www.mommysbliss.com, we identified significant violations of the…
Named company: TKO Distribution, LLC
FDA has determined that your Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies, Trippy Smak’d Fuk’d Blend Pineapple 1500 mg Gummies, and Trippy Smak’d Fuk’d Blend Grape 1500 mg Gummies are adulterated under…
Named company: Anti L’Age
Based on inspectional findings and our review of the product label collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and…
Named company: Optimal Carnivore, LLC
Potential for contamination with salmonella.
Named company: Gluten Free Remedies LLC
Food and Drug Administration _____________________ 1 This warning letter does not address whether sulbutiamine can be lawfully marketed in dietary supplements as a non-dietary ingredient.
Named company: Bio-Gen Milchserum Marketing GmbH
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Bio-Gen Milchserum Marketing GmbH Date Published : 04/15/2025…
These results describe the included collection. Sources and coverage.