FDA requires that manufactures establish and maintain procedures regarding labeling activities.
FDA expects all installation activities to be documented.
Document control is a critical part of your QMS.
If you’re thinking of handing unsigned documents to FDA during an inspection, think again.
Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.
Is your risk management process rock solid?
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
FDA appreciates nothing more than documented evidence of compliance.
Trust, but verify, your suppliers.
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.