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

The FDA issued a Warning Letter to Scientific Protein Laboratories, LLC following an inspection of their Waunakee, WI drug manufacturing facility from April 21 to May 2, 2025. The letter details significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering their APIs adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to ensure equipment surfaces in contact with raw materials do not alter API quality. Inspectors observed scratches and grooves on a processing table, indicating potential particulate contamination of animal-derived APIs like pancrelipase. The company"s response was deemed inadequate for lacking a preventive maintenance plan, material suitability evaluation, and details on particle removal, along with a missing risk assessment for potentially contaminated batches within expiry. Secondly, the company failed to establish and follow adequate written procedures for investigating critical deviations and out-of-specification (OOS) results. This included insufficient root cause analysis for assay failures during stability testing of thyroid and pancreatin lots, failure to notify customers about failing stability results, and inadequate investigations into residual solvent limit failures and BVDV-positive test results in animal-derived products. The FDA requires Scientific Protein Laboratories to conduct a retrospective review of all potentially affected API batches for particulate contamination, evaluate equipment and processes to mitigate foreign material introduction, validate their particle detection and removal methods, and implement robust operational oversight. Furthermore, the company must enhance its investigation procedures to ensure adequate root cause determination, effective corrective actions, and appropriate customer notifications for all critical deviations and OOS results.