# FDA 483 - SpecGx LLC - September 22, 2025

Source: https://www.globalkeysolutions.net/records/483/specgx-llc/cdfca736-3419-4deb-b894-3fc47a3b540d

> FDA 483 for SpecGx LLC on September 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx LLC
- Inspection Date: 2025-09-22
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of SpecGNX LLC in Raleigh, NC, an API manufacturer, revealed significant deficiencies in equipment cleaning and maintenance, air filtration systems, and overall facility upkeep, including pest control issues. The firm also failed to adequately investigate discrepancies, validate testing methods, and maintain effective quality unit procedures and laboratory controls, indicating systemic breakdowns in their quality management system.

## Related Documents

- [483 - 2025-10-22](https://www.globalkeysolutions.net/records/483/specgx-llc/54c5c4eb-56c6-431f-97d2-9efecdba9176)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/specgx-llc/b3bdc4a2-a966-484a-9ac4-f4715912e6e2

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7