# FDA 483 - Reading Hospital - July 30, 2025

Source: https://www.keypedia.com/records/483/reading-hospital/1890bcb2-929e-47f9-9046-1e5aa9e6ae43

> FDA 483 for Reading Hospital on July 30, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reading Hospital
- Inspection Date: 2025-07-30
- Product Type: biologics
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: An FDA inspection of Reading Hospital's blood bank identified significant deficiencies in its quality management system. The hospital failed to thoroughly investigate and document unexplained discrepancies related to blood product antigen testing errors and temperature control issues during transport. Additionally, the firm did not maintain adequate quality control records, specifically failing to investigate a blood storage refrigerator malfunction and complete required incident reports.

## Related Documents

- [483 - 2015-12-16](https://www.keypedia.com/records/483/reading-hospital/a34f0741-31bd-4300-88c8-349c7fa096f3)
- [483 - 2025-07-30](https://www.keypedia.com/records/483/reading-hospital/745889f8-b22d-4c16-9955-6418f09c857f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)
- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/reading-hospital/06325159-9820-479a-ba2e-0f47aaa24d60

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0