American Pharma Mfg. Inc. – FDA Warning Letter, Mar 27, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to American Pharma Mfg. Inc. following an inspection of its Ontario, California facility conducted from March 16 to March 27, 2026. The inspection revealed that the company’s dietary supplements were produced under conditions that violated the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations, rendering the products adulterated. Key violations included the failure to employ qualified quality control personnel and significant sanitation deficiencies, such as residue buildup on equipment, structural damage to walls, and inadequate pest control measures. Additionally, the company failed to establish essential identity and purity specifications for components and finished products, maintained incomplete batch production records, and failed to properly utilize metal detection equipment to prevent foreign material contamination. The FDA also noted that the firm failed to manage wastewater and toxic chemicals in a manner that protected against product contamination. Although American Pharma Mfg. Inc. provided initial responses in April 2026, the FDA determined they were insufficient due to a lack of documented evidence of corrective actions. The company is required to submit a written response within 15 working days detailing the specific steps taken to rectify these violations and prevent their recurrence. Failure to comply with these requirements may lead to legal action, including product seizures or injunctions.