CLOSEOUT LETTER
Bell International Laboratories, Inc. MARCS-CMS 669736 —
- Reference #:
- FEI 3005574978
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Paul Eichholz
-
Recipient TitleVice President of Quality & Regulatory Compliance
- Bell International Laboratories, Inc.
2950 Lexington Ave S., Suite 100
Eagan, MN 55121
United States-
- p.eichholz@bellintlabs.com
- Issuing Office:
- Division of Pharmaceutical Quality Operations III
United States
United States
Dear Mr. Eichholz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case #669736 dated February 15, 2024.
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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II