# FDA 483 - SpecGx, LLC - September 18, 2023

Source: https://www.keypedia.com/records/483/specgx-llc/fa782eca-16e5-4d10-8ad1-902887dc0f3c

> FDA 483 for SpecGx, LLC on September 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx, LLC
- Inspection Date: 2023-09-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: SpecGX, LLC, a human drug manufacturer in St. Louis, MO, was cited with two observations during an FDA inspection. The firm failed to establish and follow procedures to prevent objectionable microorganisms in non-sterile drug products, including inadequate testing for Burkholderia cepacia complex. Additionally, the firm did not thoroughly review an unexplained discrepancy related to equipment residue, with the investigation lacking microbial and chemical contamination testing and proper documentation of corrective actions.

## Related Documents

- [483 - 2021-09-17](https://www.keypedia.com/records/483/specgx-llc/bc45e382-5375-47a8-a820-74d64cf82527)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/specgx-llc/ee069c18-3128-4bbe-9c13-768b4837810f

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