Zyno Medical LLCProduct: infusion pumps Date:12/5/2016 Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example: Your firm did not open a non-conforming report (NCR) on 7/30/15, when...Read More
CSV Training Course
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.