bhp holdings inc. – FDA Warning Letter, Nov 8, 2019

The FDA conducted an inspection of the facility at 18538 142nd Avenue NE, Woodinville, Washington, from October 15, 2019, to November 8, 2019. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations, leading to the classification of dietary supplement products as adulterated and misbranded.

The dietary supplements were found to be adulterated under section 402(g)(1) of the Act due to non-compliance with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specifically, the firm failed to adequately review and investigate product complaints involving adverse events, such as reports of burning mouths/throats, nausea, stomach aches, headaches, rashes, and allergic reactions. Despite submitting revised procedures and training records, the FDA noted ongoing concerns regarding the firm's assessment of safety risks and failure to open Corrective and Preventative Actions (CAPAs) for these complaints.

Additionally, the Cocktail Liposomal, Neem Synergy, and Matrix Electrolyte Powder products were deemed misbranded under section 403 of the Act due to various labeling deficiencies (21 CFR 101). Violations included: 1. **Cocktail Liposomal:** Failure to adequately declare soy allergen sources in the required format (Section 403(w)). 2.