FDA EIR - Scientific Protein Laboratories, LLC - May 02, 2025

An FDA unannounced compliance inspection of Scientific Protein Laboratories, LLC, located in Waunakee, WI, was conducted from April 21 to May 2, 2025. This inspection served as a follow-up to a previous warning letter and involved GMP surveillance for active pharmaceutical ingredient (API) manufacturing, specifically focusing on Thyroid, Corticotropin, and Pancreatin products. The regulatory framework for this inspection was Compliance Program 7356.002F, API Process Inspection.

The inspection revealed significant deficiencies, resulting in an eight-item FDA-483. Key violations included the failure to establish and follow proper procedures for investigating critical deviations and out-of-specification API lots, and the inability to demonstrate a reproducibly manufactured API meeting quality attributes. The company also failed to validate cleaning processes, ensure scientifically sound test procedures, and maintain adequate controls over computerized systems and GMP data records. Furthermore, issues were noted regarding equipment maintenance affecting product quality and incomplete laboratory control records.

Verbally discussed concerns included unaddressed temperature monitoring alarms and potential allergen labeling for a Thyroid product. The firm committed to correcting these verbally discussed items. Due to the severity of the findings, the FDA determined an 'Official Action Indicated' for all inspected processes, recommending a Warning Letter and further follow-up by the compliance branch and center.