Scientific Protein Laboratories, LLC

Warning LetterOpen

Ms. Denise Kwiatkowski Regulatory Affairs Manager Scientific Protein Laboratories, LLC 700 East Main Street Waunakee , WI 53597 United StatesFEI 2111173Issued Oct 10, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2111173.

Violations1

Issue DateOct 10, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Scientific Protein Laboratories, LLC
Location: Ms. Denise Kwiatkowski Regulatory Affairs Manager Scientific Protein Laboratories, LLC 700 East Main Street Waunakee , WI 53597 United States
FEI Number: 2111173
Country: United States
Issue Date: October 10, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Scientific Protein Laboratories, LLC received a warning letter for manufacturing adulterated active pharmaceutical ingredients (APIs) that failed to meet Current Good Manufacturing Practice (CGMP) standards. During an April-May 2025 inspection of their Waunakee, Wisconsin facility, FDA investigators identified significant equipment deficiencies, specifically observing grooves and scratches on API contact surfaces of manufacturing tables used in pancrelipase production, which could contaminate the API with particulate matter and compromise product quality. The company had failed to ensure that equipment surfaces in contact with raw materials and APIs maintained specifications and did not alter product quality. While the company responded with corrective actions including equipment servicing, inspection, and replacement, the violations indicated systemic control failures in their manufacturing processes.

Scientific Protein Laboratories, LLC FDA Warning Letter, October 10, 2025