You established quality plans, hired an experienced team, built a quality management system, trained and retrained, prepared and practiced for regulatory inspections, diligently performed internal audits and made every effort to document it all.
And then it happens…
You just become aware that a recall is necessary, or an FDA inspection resulted in an unexpected outcome. Maybe it was a call from a health care provider reporting a product failure that leads to unexpected harm to a patient. Whatever difficult situation you may be facing, you need to react quickly and with integrity.
How your company reacts could mean the difference between a costly regulatory action and an effective resolution with minimal disruption to the business.
QualityHub’s quality, regulatory, compliance and technical experts know the most important aspects to consider when challenged with complex compliance or product issues. Here are five important points to consider for FDA remediation when your company is in a reactive mode.