FDA 483 - Lexamed, Ltd - August 04, 2022

An FDA inspection of Lexamed, Ltd in Toledo, OH, a control testing laboratory, revealed two significant observations. The firm was cited for failing to maintain equipment to prevent contamination, specifically a damaged HEPA Laminar Flow Hood. Additionally, Lexamed, Ltd did not follow established documentation practices, including issues with repeat analysis records, outdated procedures, and unexplained log book entries.