Named company: Avalon Packaging
Based on the inspection and the samples collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Pathogen…
Named company: MA Labs LLC
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 Vicaine product fails to bear adequate…
Named company: Jack B Goods Outlet Store
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 Tianaa Red, Tianaa White, and Tianaa…
Named company: DynaPro International, Inc.
Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at [see original source] we have identified serious violations of the Federal Food, Drug,…
Named company: American Botanical Pharmacy
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 Incurables Program and SuperFood Plus…
Named company: Mineralife LLC
The dietary supplement product is potentially contaminated with Pseudomonas aeruginosa
Named company: Diamond Crystal Brands, Inc.
During a label check the firm noticed that the product was shipped with the incorrect label. The label is missing the following ingredients: Soybean Oil, Onion Powder & EDTA.
Named company: Rock Farm, LLC dba WholeFood Farmacy
Based on our review, we have concluded that certain products are in violation of sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(a) and 352(f)(1)]. In…
Named company: Best Nutrition Products, Inc.
The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under…
Named company: Confidence Inc./Confidence U.S.A. Inc.
Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG).
These results describe the included collection. Sources and coverage.