Elemental Analysis, Inc.May 14, 2025

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

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Record Details

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.

Company: Elemental Analysis, Inc.
Inspection Date: May 14, 2025
Product Type: Drugs
Office: Cincinnati District Office
People: Paranthaman Senthamarai Kannan
Heather R. Campbell

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ID · 108f40a1-3b39-420c-86e6-49acfa88b923