483
Lexamed, LtdFDA 483 - Lexamed, Ltd - December 06, 2018
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LexaMed, Ltd, a contract testing laboratory in Toledo, OH, received a Form 483 for deficiencies in its laboratory control systems. The inspection revealed inadequate environmental monitoring sampling plans for microbiological bioburden testing and a failure to document sample storage conditions and locations. These issues indicate a lack of robust controls to ensure the quality and purity of drug products.
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