# FDA 483 - SpecGx LLC - September 09, 2019

Source: https://www.keypedia.com/records/483/specgx-llc/67fec33d-bdc1-4d7f-8e23-3a7fe20180cd

> FDA 483 for SpecGx LLC on September 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx LLC
- Inspection Date: 2019-09-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: SpecGx, LLC in Saint Louis, MO, was cited for significant deficiencies during an FDA inspection, including repeat observations regarding inadequate investigations of critical deviations and batch failures. The firm also failed to maintain adequate controls over computerized systems and did not submit required NDA-Field Alert Reports for distributed drug product issues. These findings indicate a systemic lack of control over quality processes and data integrity.

## Related Documents

- [483 - 2025-10-22](https://www.keypedia.com/records/483/specgx-llc/4c5da907-2510-41e1-8137-0501072d41a1)

## Related Officers

- [Ana F. Sandee](https://www.keypedia.com/people/ana-f-sandee/2f5c053f-73d2-43e3-85a3-7565d73a9d29)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

Company: https://www.keypedia.com/companies/specgx-llc/a659fe71-9183-4c7c-96ca-9214c6a9c177

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8