RecallFDA · Jul 20, 2017
Named company: Grandma's Herbs
Grandma s Herbs Cholesterol has undeclared soy lecithin.
Import alertFDA · Jul 17, 2017
Named company: Wuhan 3B Scientific Corporation
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: Wuhan 3B…
Warning letterFDA · Jul 11, 2017
Named company: Black Seed Herb, Inc.
Based on our inspection, we identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements,…
Import alertFDA · Jul 10, 2017
Named company: KINGDOM HONEY SDN BHD
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: KINGDOM…
Warning letterFDA · Jul 6, 2017
Named company: Professional Botanicals, Inc.
Based on the inspection, a review of the product labels collected during the inspection, and a review of your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the…
Import alertFDA · Jun 29, 2017
Named company: Biotivity SDN BHD
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: Biotivity…
RecallFDA · Jun 16, 2017
Named company: Threshold Enterprises Ltd
Product was inadvertently released prior to release of all QC testing. Testing had positive results for coliform growth.
RecallFDA · Jun 11, 2017
Named company: Fit and Focused Supplements
Product may be contaminated with Salmonella.
Import alertFDA · Jun 7, 2017
Named company: Bioiberica, SAU
"Detention Without Physical Examination of All Dried Shark Fins, Dried Fish Maws and Dried Shark Cartilage Powder from Shark Fins Due to Filth". Firm/address: Bioiberica, SAU Date Published : 06/07/2017 C/…
Warning letterFDA · Jun 5, 2017
Named company: Andropharm, LLC
a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). In light of the fact that they are unapproved prescription drugs, the labeling of “Sten Z” and “M1…