Warning Letter Close-Out
Definition of Warning Letter
An FDA Warning Letter is an official message from the FDA, requiring the establishment to adopt compulsory measures to address the failure of the management system or the product of the establishment to conform to FDA regulations.The Warning Letter is mainly for nonconforming management system and nonconforming products.
Necessity of Warning Letter Close-Out
If the enterprise does not timely adopt measures to close out the FDA Warning Letter, the FDA will resort to the Detention Without Physical Examination (DWPE) procedure. All devices exported by the enterprise will be confiscated automatically by the U.S. Customs.Meanwhile, the enterprise will be listed on the Import Alert. All FDA authorities, Customs and U.S. clients can obtain this information.
Method of Warning Letter Close-Out
We will adopt different measures for different reasons incurring the Warning Letter.
The method may include but not limited to:
1) Completely investigate the reasons for nonconforming system or products, and adopt systematic corrective measures;
2) After the correction, a QSR820 auditor is delegated to audit, write a report and submit it to the FDA;
3) Invite the FDA to re-audit.
4) Invite a U.S. Laboratory to test the export products, etc.
Successful experience of SUNGO
We have top professional experts on the QSR820 system. The audit report written by them can be easily understood and accepted by the FDA. We also have cooperative laboratories in the U.S., which can test and write a report timely when your products are detained by the Customs.
We successfully helped establishments in closing out the Warning Letter and the Import Alert.
It took us only 10 months to complete the project which was failed to be completed by a top world-renowned law firm for one and a half years.