FDA 483 - Wells Pharmacy, Inc - April 09, 2026

From April 6 to April 9, 2026, the FDA conducted an inspection of Wells Pharmacy, Inc., an outsourcing facility located in Dyersburg, Tennessee. The inspection identified critical failures in the firm’s production and quality control systems, specifically regarding the manufacturing of hormone pellets such as Testosterone and Estradiol. A primary concern was the lack of adequate cleaning validation; the facility could not demonstrate that its cleaning protocols effectively remove hazardous drug residues from equipment, posing a risk of cross-contamination. Furthermore, the firm failed to establish scientific justifications for its production yields. In multiple instances, batches showed exceptionally high rates of pellets failing weight requirements—with some lots having up to 43% of pellets failing to meet standards—yet these products were approved and distributed without an investigation into the root cause. Additionally, the pharmacy lacked standardized quality tests for pellet hardness, resulting in extreme variability and numerous consumer complaints regarding medication that crumbled or broke during handling. These findings were documented under the authority of the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final agency decision, it serves as a formal notification of conditions that could compromise drug safety and purity. Wells Pharmacy is expected to respond to these observations by outlining corrective measures to address the identified deficiencies and ensure future compliance with safety standards.