483Company: Schering-Plough Prodcuts, LLC City and Sate: Manati, Puerto Rico 00674-0486 FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1/01-6/13/01 You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports....Read More

Company: Electronic Data Systems (EDS)Enforcement Report Date: 6/13/01 Class: II PRODUCT: Defense Blood Standard System, Blood Bank Computer Software, – In use at 79 military facilities. Recall # B-897-1. REASON: Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not...Read More

Company: Analogic CorportationDate: 6/13/01 Class: II PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1. b) Philips Tomoscan EG. Recall # Z-551-1. c) Philips Tomoscan EG. Recall # Z-552-1. REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose. CODE: a) Philips Tomoscan M; b) Philips Tomoscan...Read More