# FDA 483 - SpecGx, LLC - September 17, 2021

Source: https://www.globalkeysolutions.net/records/483/specgx-llc/bc45e382-5375-47a8-a820-74d64cf82527

> FDA 483 for SpecGx, LLC on September 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecGx, LLC
- Inspection Date: 2021-09-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: SpecGx, LLC in Webster Groves, MO, was cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed issues with contamination control in weighing rooms, inadequate testing of water system components, and widespread failures in quality control procedures. Additionally, the facility exhibited poor equipment maintenance and unsanitary building conditions, including evidence of pest activity.

## Related Documents

- [483 - 2023-09-18](https://www.globalkeysolutions.net/records/483/specgx-llc/fa782eca-16e5-4d10-8ad1-902887dc0f3c)

## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

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

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