FDA 483 - Staska Pharmaceuticals, Inc. - February 20, 2026

Staska Pharmaceuticals, Inc., an outsourcing facility located in Bennet, Nebraska, was inspected by the FDA between February 9 and February 20, 2026. This inspection resulted in the issuance of a Form 483, detailing several significant operational failures that could compromise product safety and quality. A primary concern involved the company’s failure to investigate batch discrepancies. In one instance, a batch of injectable Ascorbic Acid proceeded to release despite failing quality sampling tests after an initial visual inspection. The firm did not conduct a root-cause analysis to determine why the initial inspection missed major defects or how this might affect other batches. The inspection also highlighted critical deficiencies in laboratory data integrity. The Quality Unit failed to review electronic raw data and audit trails for analytical systems, relying instead on printed summaries. This lack of oversight was compounded by granting analysts administrative privileges, allowing for the potential modification or deletion of test results without detection. Finally, the FDA noted flaws in the facility’s sterile processing environments. Environmental monitoring equipment was improperly positioned, obstructing the flow of filtered air over drug vials during production, which creates a risk of contamination. These observations were made under the authority of the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final agency determination, Staska Pharmaceuticals is expected to provide a written response to the FDA. This response must outline specific corrective actions to address these violations and ensure the facility adheres to standards that prevent drug contamination.