Staska Pharma Hit with FDA Form 483
FDA investigators have cited multiple quality control and aseptic processing concerns at Staska Pharmaceuticals following a February inspection of the company’s outsourcing facility in Bennet, NE, according to a newly issued Form FDA 483. The inspection identified deficiencies involving visual inspection procedures, data integrity controls for laboratory testing and environmental monitoring practices in sterile drug manufacturing operations.
Among the most significant observations, investigators said the company failed to adequately investigate discrepancies discovered during visual inspection of injectable drug products. FDA cited a July 2025 production batch of preservative-free ascorbic acid injection in which an initial 100% visual inspection rejected dozens of units for critical, major and minor defects. Subsequent Acceptable Quality Limit (AQL) sampling still identified additional major defects that exceeded the company’s acceptance criteria.
According to FDA, Staska’s quality unit allowed the batch to proceed to further reinspection and eventual release without opening an investigation into why the original full inspection failed to detect the defects later identified during sampling. Investigators also said the company’s written procedures did not require an investigation after an AQL failure.
The agency also raised extensive concerns about the reliability and oversight of high-performance liquid chromatography testing used for release of sterile drug products.
FDA said the company lacked written procedures requiring review of electronic raw data, audit trails and system-generated records associated with HPLC analyses before batch release. Investigators reported that quality control staff reviewed only printed reports and manually verified calculations, without examining underlying electronic chromatograms, deleted or repeated injections, integration changes or audit trail data.
One cited example involved a batch of preserved ascorbic acid manufactured in January in which the batch record reportedly contained only a printed HPLC summary report without documentation showing review of electronic data or audit trails. Investigators further noted that a single chemist conducted most HPLC release testing without independent electronic data review by the quality unit, creating what FDA described as insufficient safeguards against potential deletion of failed injections, selective reporting of data or manipulation of integration parameters.
FDA additionally criticized the company’s user access controls for its chromatography data system, stating that multiple employees performing HPLC analyses held administrative privileges that allowed them to modify methods, reprocess data, alter audit trail settings and add or remove users.