FDA 483 - C.A.T. GmbH and Co. KG - March 20, 2012

An FDA inspection of C.A.T. Gmbh and Co. KG, a contract testing laboratory in Tubingen, Germany, revealed deficiencies in their laboratory control mechanisms. The firm failed to properly establish and confirm system suitability for chromatographic methods used to analyze active pharmaceutical ingredients, specifically regarding the number and timing of standard solution injections. This indicates a lack of adequate quality control over critical testing procedures.