SRI Healthcare, LlcApril 16, 2026

FDA 483 - SRI Healthcare, Llc - April 16, 2026

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Record Details

An FDA Form 483 was issued to SRI Healthcare, Llc in Mason, OH, following an inspection of their manufacturing facility. The inspection revealed two observations primarily concerning deficiencies in documentation practices and the quality management system. Specifically, the firm failed to document required infrastructure maintenance activities and did not conduct management reviews of the quality system at planned intervals.

Company: SRI Healthcare, Llc
Inspection Date: April 16, 2026
Product Type: Drugs
Office: Cincinnati District Office
Person: Amber M. Capello-Jones

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ID · b4ec6c78-5342-4295-800f-c582edc0b231