FDA WARNING_LETTER - Biomin Industries, Inc. - March 15, 2017

On October 13, 2017, the FDA issued a Warning Letter to Biomin Industries, Inc. following an inspection from March 1-15, 2017. The inspection and subsequent label review revealed serious violations of the Federal Food, Drug and Cosmetic Act.

**Unapproved New Drug Violations:** Products like "(b)(4)", "(b)(4)", and "(b)(4) Antibiotc" are deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act due to therapeutic claims (e.g., "designed to eliminate inflammation," product names implying allergy or antibiotic treatment). These products lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The letter emphasizes Biomin's responsibility, even as a contract manufacturer, to ensure product labels conform to the Act.

**Dietary Supplement CGMP Violations (21 CFR Part 111):** Even if not unapproved drugs, all dietary supplements manufactured by Biomin, including those mentioned, are adulterated. Specific violations include: 1. **Failure to establish component specifications (21 CFR 111.70(b)):** No identity, purity, strength, composition, or contamination limits for components. Biomin's response was inadequate, lacking documentation. 2. **Inadequate