# FDA 483 - University of Iowa Pharmaceuticals (UIP) - June 22, 2023

Source: https://www.keypedia.com/records/483/university-of-iowa-pharmaceuticals-uip/0d3b81a3-467f-4c37-aefd-69747e4d0a0a

> FDA 483 for University of Iowa Pharmaceuticals (UIP) on June 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Iowa Pharmaceuticals (UIP)
- Inspection Date: 2023-06-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of University of Iowa Pharmaceuticals (UIP) in Iowa City, IA, revealed significant deficiencies in manufacturing controls. Observations included inadequate process validation, failure to conduct specific identification tests on components, insufficient aseptic process validation, and a lack of proper procedures for investigating product complaints. These issues indicate a need for comprehensive corrective actions to ensure product quality and patient safety.

## Related Documents

- [EIR - 2018-05-04](https://www.keypedia.com/records/eir/university-of-iowa-pharmaceuticals-uip/3fea062b-f0f9-4ac2-8199-384728a1b583)
- [483 - 2018-05-04](https://www.keypedia.com/records/483/university-of-iowa-pharmaceuticals-uip/8ae41f26-42c0-4755-a9d2-5b41cc643193)

## Related Officers

- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.keypedia.com/companies/university-of-iowa-pharmaceuticals-uip/02fb53f6-b096-4068-a52e-9e38cea7fa0d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8