FDA 483 - Wells Pharmacy, Inc - April 25, 2025

The FDA conducted an inspection of Wells Pharmacy, Inc., an outsourcing facility located in Dyersburg, TN, from April 14 to April 25, 2025. The inspection revealed several critical compliance issues under the regulatory framework of the Food, Drug, and Cosmetic Act (FD&C Act).

Key violations included the failure to perform necessary dissolution testing for controlled-release drug products, such as various dosages of Estradiol, Progesterone, and Testosterone, which is essential to ensure the reproducibility of the release rate of active ingredients. Additionally, the firm’s container closure systems were found inadequate in protecting sterile drug products from contamination over their shelf life, as the integrity study was not extended to match the assigned beyond-use dates (BUDs).

The Quality Unit did not establish appropriate specifications for the hardness of implantable hormone pellets, resulting in a wide range of intra-batch hardness and contributing to adverse events and complaints about pellet extrusions and breakages. Furthermore, the drug product labels did not comply with FD&C Act Section 503B(a)(10)(A), lacking essential information such as the statement "This is a compounded drug," facility contact details, dosage form, strength, and other critical labeling requirements.

The FDA requires Wells Pharmacy to address these violations by implementing corrective actions to ensure compliance with regulatory standards. This includes conducting appropriate laboratory tests, enhancing container closure systems, establishing robust quality specifications, and updating product labels to meet statutory requirements.