General Hearing Instruments, Inc.. Product: ready-wear-air conduction hearing aids Date: 9/18/2013 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current...Read More
Company: B Braun Medical, Inc. Date of Enforcement Report: 9/18/2013 Class lI: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...Read More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.