FDA 483 - Scientific Protein Laboratories, LLC

Scientific Protein Laboratories, LLC in Waunakee, WI, received a Form 483 with eight observations during an inspection of its drug substance manufacturing facility. The inspection revealed significant deficiencies, including inadequate investigations into out-of-specification results and stability failures, and a lack of demonstrated reproducibility in manufacturing and cleaning processes. Further issues involved insufficient controls over computerized systems, poor equipment maintenance, uncontrolled GMP logbooks, and inaccurate laboratory records, indicating systemic quality control and data integrity concerns.