483
SRI Healthcare, LlcSRI Healthcare, Llc – FDA 483, Apr 16, 2026
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.
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