Recipient: Spinetronics, LLC .Product: Antalgic-Trak Date: 7/25/2011 Violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures....Read More
Company: Blood Bank Computer Systems, Inc.Date of Enforcement Report 8/17/11 Class ll: PRODUCT Blood Bank Computer Service (BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M. The device is a software application used by blood banking firms to track donor information at remote sites to eventually link up with the Primary Application that is linked to...Read More
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