# FDA 483 - Transpire Bio Inc. - October 01, 2025

Source: https://www.globalkeysolutions.net/records/483/transpire-bio-inc/533b071f-f40d-4abf-8194-50a59b2e68fb

> FDA 483 for Transpire Bio Inc. on October 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Transpire Bio Inc.
- Inspection Date: 2025-10-01
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Transpire Bio Inc., a manufacturer of dry inhalation drugs in Weston, FL, was cited for significant quality control and documentation deficiencies during an FDA inspection. Observations included the failure of the quality unit to review audit trails before product release, inadequate quarantine procedures for incoming materials, and poorly designed equipment logbooks leading to inconsistent and missing batch information. These issues indicate a lack of robust control over manufacturing processes and data integrity.

## Related Documents

- [483 - 2025-11-07](https://www.globalkeysolutions.net/records/483/transpire-bio-inc/ab087473-b487-49fb-9037-86b5cbd5dd17)

## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Mickell Smith](https://www.globalkeysolutions.net/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)

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

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