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Main Citation "Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))." 6 Detailed Analysis of the Violation "Technical Issues" as Compliance Failures: The firm failed to provide 2023 media fill records, attributing the absence to "technical issues".6 Media fills are the primary validation of aseptic processing