# FDA 483 - Reading Hospital - July 30, 2025

Source: https://www.keypedia.com/records/483/reading-hospital/745889f8-b22d-4c16-9955-6418f09c857f

> 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: Philadelphia District Office
- Summary: An FDA inspection of Reading Hospital's blood bank identified significant deficiencies. The firm failed to thoroughly investigate unexplained discrepancies in blood product testing and temperature control for platelet units. Additionally, the inspection revealed a failure to maintain quality control records for blood storage equipment and to complete required incident reports for equipment failures.

## 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/1890bcb2-929e-47f9-9046-1e5aa9e6ae43)

## 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/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8