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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: KeeptheFaith who wrote (49309)1/20/2019 1:53:34 PM
From: Rivegauge  Respond to of 63332
 
KTF- generally having missing SOOs for a start up company and I put a remediation plan with timeline which was overseen by head of QA and I reported in to the leadership

Also site violations

For manufacturing, can also be SOPS.
Main thing , sponsor after audit should present corrective action plan with timeline and adhere to it . Providing regular agreed upon updates to fda . Monitored by WA , I presented or were shared by senior management and the board


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