# FDA 483 - Eclipse Technology Solutions Inc - May 01, 2024

Source: https://www.keypedia.com/records/483/eclipse-technology-solutions-inc/5980f72a-c639-4d6a-89eb-f81f01066fa4

> FDA 483 for Eclipse Technology Solutions Inc on May 01, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eclipse Technology Solutions Inc
- Inspection Date: 2024-05-01
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Eclipse Technology Solutions Inc in Chadds Ford, PA, a human tissue establishment, revealed significant deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included failures to record and periodically review HCT/P storage temperatures. Additionally, the firm lacked documented procedures for determining the suitability of returned HCT/Ps for inventory.

## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)

Company: https://www.keypedia.com/companies/eclipse-technology-solutions-inc/87bd43f9-87cb-4708-abcc-2ec5481fda9a

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