# FDA 483 - Longhorn Vaccines And Diagnostics LLC - October 30, 2025

Source: https://www.globalkeysolutions.net/records/483/longhorn-vaccines-and-diagnostics-llc/413218c2-79a7-45ce-895c-02ab9629ce65

> FDA 483 for Longhorn Vaccines And Diagnostics LLC on October 30, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Longhorn Vaccines And Diagnostics LLC
- Inspection Date: 2025-10-30
- Product Type: device
- Office Name: Baltimore District Office
- Summary: Longhorn Vaccines And Diagnostics LLC, a medical device manufacturer in Bethesda, MD, was inspected and found to have significant deficiencies in its quality system. The inspection revealed a widespread failure to establish and maintain required quality system procedures, including those for management review, audits, design controls, complaints, and CAPA. Additionally, the firm lacked a proper design history file for its PrimeStore® MTM device, failing to document design development and changes.

## Related Officers

- [Andrea D. Gomez](https://www.globalkeysolutions.net/people/andrea-d-gomez/778adaf5-c531-419f-b262-4569991fcae8)
- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/longhorn-vaccines-and-diagnostics-llc/ccee99c7-4da9-4a9f-b223-363500d1243a

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa