FDA 483 - Right Value Drug Stores LLC - September 08, 2026

Right Value Drug Stores LLC, a 503B outsourcing facility in Irving, Texas, underwent an FDA inspection between August 24 and September 8, 2026. The resulting Form 483 highlights several significant safety and quality control deficiencies, many of which are recurring issues from previous inspections. Key violations include inadequate airflow studies to ensure sterile environments during drug production and the release of various estradiol hormone pellets without essential testing for quality, strength, and consistency. The facility’s Quality Unit demonstrated significant oversight failures, including the use of an uncertified laboratory for microbial identification and the failure to complete annual product reviews by required deadlines. Furthermore, the firm failed to investigate critical equipment malfunctions and a substantial increase in mold detection within their clean rooms, which rose from 8% to 33% over a single year. Additional concerns involve inconsistent environmental monitoring and the use of improperly calibrated weighing scales for production. These findings are issued under Section 704 of the Federal Food, Drug, and Cosmetic Act. While this document is not a final determination of compliance, the company is expected to address these observations promptly. Required actions include discussing these findings with the FDA and submitting a formal written response outlining corrective actions to resolve the identified risks to product sterility and patient safety.