# FDA 483 - Transpire Bio Inc. - November 07, 2025

Source: https://www.keypedia.com/records/483/transpire-bio-inc/ab087473-b487-49fb-9037-86b5cbd5dd17

> FDA 483 for Transpire Bio Inc. on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Transpire Bio Inc.
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Transpire Bio, Inc. in Weston, FL, a biopharmaceutical analytical facility, was cited for three observations during an FDA inspection. The firm's study reports did not accurately disclose all study activities, including erroneous data reporting and omitted protocols. Additionally, a full method validation was not completed prior to conducting sample analysis for an in vitro bioequivalence study, and the firm failed to retain reserve samples from all shipments of reference standards.

## Related Documents

- [483 - 2025-10-01](https://www.keypedia.com/records/483/transpire-bio-inc/533b071f-f40d-4abf-8194-50a59b2e68fb)

## Related Officers

- [Angelica M. Chica](https://www.keypedia.com/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)
- [Yiyue C. Zhang](https://www.keypedia.com/people/yiyue-c-zhang/bb9e053e-ff20-4724-b4dc-1ee2e8f23833)

Company: https://www.keypedia.com/companies/transpire-bio-inc/f2ab3def-2519-4172-8194-14a7f372db87

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9