UPDATE : US FDA Warning Letter related to excipients produced by DuPont at 1301 Ogletown Rd, Newark, DE 19711, United States.

Further to our notice of 09 February 2023 which informed the excipient community that the EXCiPACT certificate for this site has been suspended for a period of six months, EXCiPACT has been in close communication with both the site itself and the certification body as to next steps in the interim period.

With the certification body, EXCiPACT participated in an onsite review of documentation associated with the site’s corrective and preventive actions, a report of which has been reviewed by the EXCiPACT Management Body. The MB concurs with the conclusions of the report that sufficient progress in response to the FDA Warning Letter has been made to reinstate the site’s EXCiPACT GMP certificate. The EXCiPACT website will be updated accordingly.

The EXCiPACT audit cycle for maintenance of the certificate will now be resumed as normal. It is a requirement of the EXCiPACT scheme that the report will be available to relevant interested parties on request to the site.’

EXCiPACT appreciates the co-operation of both the site and the certification body to achieve this outcome. EXCiPACT wishes to reassure users of the EXCiPACT certification scheme that the decision to reinstate the GMP certificate was taken after rigorous assessment and due consideration of the GMP practices now in place at the site.  

Meanwhile, within EXCiPACT itself, appropriate review has been completed and actions have been identified to enhance the robustness of scheme as a result of this regulatory action, which are in the process of being implemented.

For further details, contact info@excipact.org or +32 (0)2 213 74 49.