483
Lexamed, LtdFDA 483 - Lexamed, Ltd - April 08, 2022
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Record Details
Lexamed, Ltd, a control testing laboratory in Toledo, OH, received a Form 483 with two observations. The inspection revealed issues with equipment maintenance, specifically a damaged HEPA laminar flow hood, and significant deficiencies in documentation practices, including unrecorded repeat analyses, outdated procedures, and unexplained logbook alterations.
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