Named company: Dominant Nutrition LLC formerly 8 Weeks Out Labs
Based on a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and applicable regulations. Adulterated Dietary Supplement Labeling on your…
Named company: New Green Nutrition, Inc.
Misbranded Drugs Your “Xiao Ke Wan,” “Diabetee-Care” and “Specific Jiang Tang Remedy” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their…
Named company: Quicksilver Scientific
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Nanoemulsified Milk Thistle, Cat’s Claw…
Named company: Organa International Corp.
Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at the Internet address…
Named company: AriBio H&B Co., Ltd.
The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated within the meaning of…
Named company: ULTRAtab Laboratories, Inc.
cGMP Deviations
Named company: ULTRAtab Laboratories, Inc.
cGMP Deviations
Named company: ULTRAtab Laboratories, Inc.
cGMP Deviations
Named company: ULTRAtab Laboratories, Inc.
cGMP Deviations
Named company: ULTRAtab Laboratories, Inc.
cGMP Deviations
These results describe the included collection. Sources and coverage.