# FDA 483 - University of Iowa Pharmaceuticals (UIP) - May 04, 2018

Source: https://www.globalkeysolutions.net/records/483/university-of-iowa-pharmaceuticals-uip/8ae41f26-42c0-4755-a9d2-5b41cc643193

> FDA 483 for University of Iowa Pharmaceuticals (UIP) on May 04, 2018. 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: 2018-05-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: University of Iowa Pharmaceuticals (UIP) in Iowa City, IA, was inspected and cited for four observations. Key issues included using expired ingredients without scientific justification for stability, inadequate validation of test methods for visual acuity, media-fills not simulating actual manufacturing processes, and deficient complaint procedures leading to unreported adverse drug reactions. These findings indicate significant concerns regarding quality control, aseptic processing, and post-market surveillance.

## Related Documents

- [EIR - 2018-05-04](https://www.globalkeysolutions.net/records/eir/university-of-iowa-pharmaceuticals-uip/3fea062b-f0f9-4ac2-8199-384728a1b583)
- [483 - 2023-06-22](https://www.globalkeysolutions.net/records/483/university-of-iowa-pharmaceuticals-uip/0d3b81a3-467f-4c37-aefd-69747e4d0a0a)

## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

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

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