FDA 483 - Hillyard GMP - February 27, 2026

During an inspection of the Hillyard GMP drug manufacturing facility in Saint Joseph, Missouri, conducted between February 23 and February 27, 2026, the Food and Drug Administration (FDA) identified significant deficiencies in the firm"s quality management systems. The primary violation involved the company"s failure to follow its own internal procedures for qualifying and approving component suppliers. Although the firm"s protocols required conducting paper audits of vendors, investigators found that these audits were not performed for suppliers involved in the production of drug products. Specifically, Hillyard GMP lacked any documentation showing that the Quality Unit had evaluated or approved suppliers prior to using their materials. There were no completed supplier questionnaires, audit records, or defined quality agreements establishing clear expectations and responsibilities for vendors. These observations were issued under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the FDA 483 form does not represent a final agency determination of compliance, the company is required to respond. Hillyard GMP must provide a written explanation of its corrective actions or any objections to these findings to the FDA"s Kansas City District office to ensure future regulatory adherence and the safety of its manufacturing chain.