# FDA 483 - Eurofins CellTx Inc - September 20, 2024

Source: https://www.globalkeysolutions.net/records/483/eurofins-celltx-inc/12439c97-b1c2-4ee9-be47-94c47120db60

> FDA 483 for Eurofins CellTx Inc on September 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins CellTx Inc
- Inspection Date: 2024-09-20
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Eurofins CellTx Inc in Tucson, AZ, received a Form 483 for significant deficiencies in its RCDAD laboratory operations. Observations included inaccurate client reports, inadequate deviation investigations, poor documentation of cleaning and maintenance, and unvalidated water systems and testing equipment. The findings indicate a systemic lack of control over critical laboratory processes and record-keeping.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)
- [investigator](https://www.globalkeysolutions.net/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)
- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/eurofins-celltx-inc/8aebff21-84c3-473c-975c-c80f006843c5

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face