FDA 483 - Eosera, Inc. - March 20, 2026

From March 16 to March 20, 2026, the Food and Drug Administration (FDA) conducted an inspection of Eosera, Inc., a drug manufacturing facility located in Fort Worth, Texas. The inspection identified several significant deficiencies across the company’s quality, laboratory, and production systems. Key issues included the failure to reject defective packaging materials, which resulted in the distribution of leaking products and numerous consumer complaints. The firm also utilized research-and-development samples and unverified raw materials in commercial batches without performing required testing or maintaining proper documentation. Laboratory controls were found to be insufficient, as the company lacked scientifically sound procedures to ensure the identity, strength, and purity of its products. Specifically, the firm failed to establish necessary specifications for several drug products and dismissed out-of-specification stability test results without adequate investigation. Additionally, production processes were not properly validated before products were released for sale, and equipment cleaning procedures were not tested to ensure they effectively removed contaminants. The facility also failed to re-qualify critical stability chambers after moving to a new location and neglected to calibrate measuring instruments on schedule. These observations indicate that the firm is not meeting the required standards for drug manufacturing as established by federal regulations. While this report does not represent a final agency determination, Eosera, Inc. is expected to provide a written response to the FDA outlining its planned corrective actions to address these violations and ensure future compliance.