CLOSEOUT LETTER
DuPont Nutrition USA Inc. MARCS-CMS 627211 —
- Reference #:
- FEI 3013947845
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Shoba Reddy Chagam
-
Recipient TitleHead of Global Regulatory Affairs & Head of Regulatory Affairs Americas
- DuPont Nutrition USA Inc.
- Roquette Health and Pharma Solutions BG
1301 Ogletown Road
Newark, DE 19711-5419
United States
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
United States
United States
Dear Mr. Chagam:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #627211, dated December 2, 2022.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
LaKeesha M. Sifontes
Group Supervisor
Division of Drug Quality II