Warning letterFDA · Jan 30, 2023
Named company: Old Tiles Wallpaper, LLC DBA Old Tiles Decor
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “Wind…
Warning letterFDA · Jan 24, 2023
Named company: Adept Life Science, LLC
Based on the inspectional findings we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. The inspection of your facility revealed serious…
Warning letterFDA · Jan 23, 2023
Named company: Zing Brothers LLC
Based on inspectional findings and a review of your labels for (b)(4) and (b)(4) , we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.…
Safety advisoryFDA · Jan 18, 2023
Named company: The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC
The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing…
Import alertFDA · Jan 18, 2023
Named company: Pharmalab 1982 Inc. Dba. Ideal Protein
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Pharmalab 1982 Inc. Dba. Ideal Protein Date Published : 01/18/2023 8750…
RecallFDA · Jan 12, 2023
Named company: Ortho Molecular Products, Inc.
Raw material tested positive for Cronobacter sakazakii.
Warning letterFDA · Jan 10, 2023
Named company: HIS Enterprise Inc dba Adam’s Secret USA, LLC
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Reade Slim…
Warning letterFDA · Jan 9, 2023
Named company: Distributor RFR, LLC
Based on the inspection and review of your product labeling, including your firm’s website, FDA determined that “SANGTER Energy Supplement” is an unapproved new drug sold in violation of sections 505(a) and…
Import alertFDA · Jan 9, 2023
Named company: LAMBO Laboratoria
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: LAMBO Laboratoria Date Published : 01/09/2023 Industriepark Den Hoek 3 ,…
Warning letterFDA · Dec 13, 2022
Named company: Quality Supplement Manufacturing, Inc.
Based on inspectional findings and a review of your product labels, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We have reviewed that…