# FDA 483 - Nexus Pharmaceuticals Inc - January 20, 2023

Source: https://www.keypedia.com/records/483/nexus-pharmaceuticals-inc/888ce7bc-b79c-4514-aef9-c8124438ba2d

> FDA 483 for Nexus Pharmaceuticals Inc on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nexus Pharmaceuticals Inc
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Nexus Pharmaceuticals Inc in Pleasant Prairie, WI, a manufacturer and packager of drug products, revealed significant deficiencies. Observations included inadequate handling and storage of rejected components, failure to validate supplier test results for stoppers, and a lack of proper controls over electronic batch records and computer systems, including shared login credentials. These issues indicate a need for improved quality control and data integrity practices.

## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)
- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/nexus-pharmaceuticals-inc/3aeda496-5b50-4663-8073-e568e4076eae

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