FDA 483 - Brio Pharmaceuticals Inc - February 27, 2026

Brio Pharmaceuticals Inc., a prescription drug manufacturer located in Houston, Texas, underwent a regulatory inspection by the FDA from February 23 to February 27, 2026. The inspection identified several critical deficiencies in the facility"s adherence to required manufacturing standards. Specifically, the firm failed to provide mandatory annual training on Good Manufacturing Practices to its employees and temporary workers during 2024 and 2025. Additionally, the quality control unit did not consistently apply quarantine or approval labels to material containers and pallets, leading to potential confusion regarding the status of raw materials. Investigators also discovered that the company failed to follow its own stability testing protocols. Temperature mapping studies, which ensure uniform environmental conditions, had not been conducted for specific stability chambers used to test drug solutions. These observations were issued under the Federal Food, Drug, and Cosmetic Act to highlight practices that deviate from safety and quality regulations. While these findings do not constitute a final agency determination, the company is required to address these issues by discussing corrective actions with the FDA or submitting a formal written response outlining their plan for remediation.