# FDA 483 - Scientific Protein Laboratories, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/scientific-protein-laboratories-llc/cc2c7d0e-2169-4fa6-bb62-70e72e989947

> FDA 483 for Scientific Protein Laboratories, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scientific Protein Laboratories, LLC
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

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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