# HCSC-Blood Center – FDA 483, Jul 20, 2026

Source: https://www.keypedia.com/records/483/hcsc-blood-center/9274a385-7916-43d6-9b14-44ebc4f4527d

> FDA 483 for HCSC-Blood Center on July 20, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HCSC-Blood Center
- Inspection Date: 2026-07-20
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of HCSC-Blood Center in Bethlehem, PA, a blood bank, identified two significant observations. The firm failed to maintain adequate storage, distribution, and quality control records, specifically lacking documentation for unit inspection and temperature of returned and reissued blood products. Additionally, written standard operating procedures for blood collection were not consistently followed, as evidenced by improper handling and timing of a platelet unit.

## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)
- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/hcsc-blood-center/ab4b1fa5-6452-4a15-bc98-d2056be7c27b

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8