CLOSEOUT LETTER
Azurity Pharmaceuticals, Inc. MARCS-CMS 656489 —
- Reference #:
- FEI 3003395329
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Ronald Scarboro
-
Recipient TitleCEO
- Azurity Pharmaceuticals, Inc.
900 Ridgefield Drive
Raleigh, NC 27609
United States-
- rscarboro@azurity.com
- Issuing Office:
- Center for Drug Evaluation and Research (CDER)
United States
United States
Dear Mr. Scarboro:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (656489) dated September 20, 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/
Carmelo Rosa, Psy.D.
Director, Division of Drug Quality I
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
CC:
Ms. Marie Romanow
Director of Quality Compliance
Azurity Pharmaceuticals, Inc.
8 Cabot Road, Suite 2000
Woburn, MA 01801
marie.romanow@azurity.com