Avid Bioservices Inc (CDMO)

[freethemice]

Found this FDA document which might shed some light on how these errors were discovered.
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219488.htm
page 63 (of 63). The first document listed


So I assume that in the process of compiling this document they found the errors and that triggered an audit to be
done by an independent organization. I assume the errors were discovered during this phase to wrap up everything
before talking to FDA about phase 3 trial.