483
Lexamed, LtdFDA 483 - Lexamed, Ltd - December 06, 2018
Record Details
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.
Open in Dashboard
ID · b6149be9-f1da-47a4-8d44-e0f23ccf3499