FDA 483 - BioChem Sioux City Inc. - March 19, 2026

From March 17 to March 19, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of BioChem Sioux City, Inc., a facility located in Sioux City, Iowa, specializing in the manufacture of heparin sodium crude. The inspection, documented on Form 483, identified two primary deficiencies within the firm’s laboratory systems. First, the company failed to maintain an ongoing stability program to support the expiration dates of its products; the only available stability report dated back to 2018, with no subsequent studies conducted through 2026. Second, the firm has been using an unvalidated, modified assay method for product testing and release for approximately 15 to 20 years. Without proper validation, the reliability and accuracy of this testing method cannot be assured. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act to assist the firm in achieving compliance. BioChem Sioux City is required to address these findings by discussing any objections with the FDA or submitting a comprehensive plan for corrective actions. This document serves as a notification of objectionable conditions rather than a final agency determination of compliance status.