May 23, 2007
Recipient: Medico Labs, Inc. Product:drug products Date:4/16/2007 An inspection of your manufacturing facility was conducted from November 2 through November 16, 2006. During the inspection, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) Regulations, Title 21 Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211) for drug products...
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Company:GE Healthcare-Americas Signa 3.0T EXCITE Date of Enforcement Report:5/23/2007 Class:ll PRODUCT GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance system, Recall # Z-0815-2007 REASON To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included...
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