FDA 483 - Accra-Pac, Inc. - March 05, 2026

Between February 26 and March 5, 2026, the U.S. Food and Drug Administration (FDA) inspected Accra-Pac, Inc., an over-the-counter drug manufacturing facility in Elkhart, Indiana. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified several critical deficiencies in quality control and data integrity. Key issues included inadequate computer system security, where shared administrative privileges allowed unauthorized personnel to modify or delete laboratory data. The firm also lacked sufficient scientific validation for its manufacturing processes and failed to follow established protocols for auditing raw material suppliers. Additionally, the inspection revealed a failure to document equipment cleaning times and a lack of proper labeling for chemical storage tankers, which increases the risk of product contamination and ingredient mix-ups. Although these observations are not a final determination of non-compliance, Accra-Pac, Inc. is expected to respond to the FDA with a detailed plan for corrective actions. The firm must demonstrate how it will resolve these procedural gaps to ensure that its drug products maintain the required identity, strength, and purity.