# FDA 483 - Elemental Analysis, Inc. - May 14, 2025

Source: https://www.globalkeysolutions.net/records/483/elemental-analysis-inc/108f40a1-3b39-420c-86e6-49acfa88b923

> FDA 483 for Elemental Analysis, Inc. on May 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elemental Analysis, Inc.
- Inspection Date: 2025-05-14
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Elemental Analysis, Inc., a control testing laboratory in Lexington, KY, revealed significant deficiencies across multiple areas. The firm failed to adequately investigate nonconformances, lacked essential quality control procedures, and demonstrated poor control over computer systems and data integrity. Additionally, issues were noted with instrument calibration and employee training programs.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Heather R. Campbell](https://www.globalkeysolutions.net/people/heather-r-campbell/aaf80125-4322-45fe-a0f6-30cea8f1dbd2)

Company: https://www.globalkeysolutions.net/companies/elemental-analysis-inc/29307a33-c2b2-4ddf-ae7b-7c76e84cfce8

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22