# FDA 483 - Indiana University Health - June 12, 2019

Source: https://www.globalkeysolutions.net/records/483/indiana-university-health/71a93bc2-b518-45ce-b141-16f386d81fc8

> FDA 483 for Indiana University Health on June 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana University Health
- Inspection Date: 2019-06-12
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Indiana University Health in Indianapolis, an establishment handling Blood Bank & HCT/P, revealed a significant issue with equipment maintenance. Specifically, cryogenic freezers used for storing human tissues were not maintained according to manufacturer's guidelines, indicating a lapse in established schedules for critical equipment. This suggests a moderate severity finding related to facility and equipment controls for HCT/Ps.

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/indiana-university-health/363f4300-ebcc-4fdb-baf9-4a12dfa447ab

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0