# FDA 483 - Scientific Protein Laboratories, LLC - April 21, 2025

Source: https://www.keypedia.com/records/483/scientific-protein-laboratories-llc/c8274da7-1043-4f32-ba84-cb80826acc87

> FDA 483 for Scientific Protein Laboratories, LLC on April 21, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scientific Protein Laboratories, LLC
- Inspection Date: 2025-04-21
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: Scientific Protein Laboratories, LLC, located in Waunakee, WI, underwent an FDA inspection from April 21-25 and April 30-May 1, 2025. The inspection revealed significant compliance issues related to the manufacturing of drug substances. Key violations included the failure to establish and adhere to written procedures for investigating critical deviations and out-of-specification (OOS) results. Notably, the firm did not adequately investigate the root causes of OOS results, extend findings to other potentially affected products, or implement corrective and preventive actions. For instance, investigations into certain API batches identified contamination with excess lymph node material, yet the impact on other batches from the same supplier was not thoroughly assessed.

Additionally, stability failure investigations were not extended to all commercially distributed batches. Some products were released at the lower limit of specifications without evaluating other batches for similar issues. The firm also failed to notify customers of OOS results for certain batches that remained on the market.

The FDA's observations highlight a lack of robust quality control measures and inadequate process validation, which are critical under the regulatory framework to ensure product safety and efficacy. The company is required to address these deficiencies by implementing comprehensive corrective actions, including revising investigation procedures, enhancing stability testing protocols, and ensuring all products meet quality specifications before distribution. These actions are essential to comply with FDA regulations and maintain product integrity.

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## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)
- [investigator](https://www.keypedia.com/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/scientific-protein-laboratories-llc/9d993d9f-a965-436a-ba5b-d9709935e5a7

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d