PCI Pharmaceutical Consulting Israel Ltd 8/82 Barr and OOS Faced with potential closure, the company took FDA to court The judge went into great details as to the meaning and implications of OOS results The outcome: FDA draft guidance: 1998 FDA final guidance: 2006
{"Image DocumentName": "The Barr Court Case and Judge Wolin", "Image ImageDescription": "From the New York Times. February 6, 1993, Saturday. (AP); Financial Desk. COMPANY NEWS; Judge Rules On Barr Labs. A generic drug manufacturer must recall batches of some of its medicines and stop distributing others until the company completes studies of its manufacturing process, a Federal judge ruled on Thursday. But United States District Judge Alfred M. Wolin refused a request by Federal pharmaceutical regulators to order a complete shutdown. PCI Pharmaceutical Consulting Israel Ltd.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}