Manage FDA Warning Letter Commitments and Oversee Technology Transfer

In 2019-2020, GMP Consultants was selected to assist a team of experts in Pontoise, FRANCE to implement remediation actions in response to a FDA Warning Letter given to a leading cosmetic company.

After 3 months, GMP Consultants was solicited to take over as Team Leader of the consultants and compliance task forces.

Responsibilities included managing a team of twelve (12) senior consultants, implementing and overseeing all commitments to the FDA, drafting follow-up responses to the FDA and managing the Steering Committee.  

GMP Consultants remained on the project for 15 months and were also involved in overseeing the Technology Transfer of products from FRANCE to the USA.

The project resulted in the successful completion of all corrective actions identified in the Warning Letter and Transfer of GMP products to CMO.