You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit. It is helpful for a site to know what the FDA auditor will use during their review. In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations.
Topics: Audit Prep, BIMO Checklist, FDA
