Not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.
All device establishments may suffer from the occasional “solecism” or inaccuracies associated with managing a dynamic quality management system, however, when nine Form 483 observations are documented in an agency warning letter, the QA and RA folks are more than likely fast asleep at the proverbial wheel.
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
If an establishment is executing corrections and removals and failing to notify FDA, then rest assured, a warning letter is in your establishment’s future; and no crystal ball is required to see into the future.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
FDA has given device establishments a gift in regard to the vagueness of the RI requirement. It is up to each device establishment to decide how much RI is required. However, at the end of the day the approach for RI must be defendable during an agency inspection, and when in doubt, the approach to RI should be risk-based.
Device History Records are not optional. So do not be that Chief Jailable Officer that has to sit across from that FDA investigator without the documented evidence of compliance needed to defend your establishment’s QMS (or lack of it).
Remember these takeaways: When nonconforming product is identified, quickly bag it and tag it. Make sure the disposition process is well documented, including evidence of an investigation to support it; and use a locked quarantine.
If an organization fails to practice cGMP compliance, chances are good that either the QMS is poorly constructed or the management team is clearly disconnected from the QMS process.
Do not be that establishment that fails to fully establish procedures or collect relevant information needed to support claims of compliance with the QSR.
