FDA 483 - Delta Pharma, Inc. - November 10, 2025

During an inspection conducted from November 10 to November 21, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Delta Pharma, Inc., an outsourcing facility located in Ripley, MS. The inspection identified two significant observations concerning the firm"s compliance with drug manufacturing regulations. The first observation noted that the labels for several batches of the firm"s semaglutide finished drug products lacked essential information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 503B(a)(10)(A). Specifically, primary labels did not include Delta Pharma"s address, nor the mandatory statements "NOT FOR RESALE" and "OFFICE USE ONLY." The second observation highlighted a deficiency in material system controls. Approved components, such as Sterile Water for Injection, USP, were not adequately retested or reexamined for identity, strength, quality, and purity after extended storage periods before being used in drug production. This issue was specifically noted for a lot of sterile water used in a semaglutide product, indicating a potential risk to product quality and patient safety. Delta Pharma, Inc. is required to address these observations by implementing appropriate corrective actions to ensure compliance with federal regulations regarding drug product labeling and quality control for raw materials. The FDA 483 document serves as a notification of objectionable conditions, and the firm"s response detailing its corrective measures is expected.