The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
Managing suppliers is critical, and your processes in doing so must be documented.
Failure to comply with FDA’s wishes landed three companies warning letters.
Audits are the cornerstone of a QMS.
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?