# FDA 483 - Tri Tech Laboratories LLC dba KDC/One Columbus - December 19, 2023

Source: https://www.keypedia.com/records/483/tri-tech-laboratories-llc-dba-kdcone-columbus/2dd4852e-0a6f-492f-9e70-2295c9560565

> FDA 483 for Tri Tech Laboratories LLC dba KDC/One Columbus on December 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tri Tech Laboratories LLC dba KDC/One Columbus
- Inspection Date: 2023-12-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Tri Tech Laboratories LLC dba KDC/One Columbus in New Albany, OH, was cited for significant deficiencies in quality control and laboratory practices during an FDA inspection. The observations highlight a systemic failure to adequately test raw materials and finished products, investigate out-of-specification results, maintain proper documentation, and control computer systems. These issues indicate a lack of robust quality assurance for their antibacterial hand gels and sanitizers.

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/tri-tech-laboratories-llc-dba-kdcone-columbus/ac73e1d6-0290-420a-989f-bf437d9f0891

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0