FDA 对 NeilMed Pharmaceuticals Inc. 发出关闭信（MARCS-CMS 650263，2026年10月19日）
NeilMed Pharmaceuticals Inc. - 650263 - 10/19/2026
FDA 已对 NeilMed Pharmaceuticals Inc. 针对其2023年5月26日警告信所采取的纠正措施完成评估，认为该公司已解决警告信中列出的违规问题。该关闭信（MARCS-CMS 650263）于2026年10月19日发出，FDA 表示未来检查与监管活动将进一步评估这些纠正措施的充分性与可持续性。
CLOSEOUT LETTER
NeilMed Pharmaceuticals Inc. MARCS-CMS 650263 — October 19, 2026
- Reference #:
- FEI 3002998723
- Product:
- Drugs
- Recipient:
-
Recipient Name
Dr. Ketan C. Mehta
-
Recipient Title
Founder and Chief Executive Officer
- NeilMed Pharmaceuticals Inc.
5555 Mehta Drive
Santa Rosa, CA 95403
United States
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
United States
United States
Secondary Issuing Offices
Dear Dr. Mehta:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated May 26, 2023.
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/
Emily Stoklosa
Compliance Officer
Division of Drug Quality I
来源：FDA 官方药品与生物制品信息 · fda.gov