FDA acknowledgement of Prodrome Sciences USA compliance response
On March 19, 2026, the FDA's Center for Drug Evaluation and Research acknowledged Prodrome Sciences USA's January 29 response to observations from an inspection conducted between December 17, 2024 and January 10, 2025. The letter confirms that the corrective actions described in Prodrome's response are adequate to bring the company into compliance with FDA regulations, and that the correspondence is entered as a permanent part of Prodrome's regulatory file.
Original document
Transcription
Prodrome Sciences USA, LLC
Attention: Dayan B. Goodenowe, Ph.D., CEO
27518 Via Industria
Temecula, California 92590
Dear Dr. Goodenowe:
We acknowledge receipt of your correspondence dated January 29, 2026, in response to our letter of January 8, 2026, regarding observations made during our inspection conducted between December 17, 2024, and January 10, 2025.
We trust that the actions described in your letter will provide adequate measures to bring Prodrome Sciences USA, LLC into compliance with FDA regulations. Any written response and all correspondence will be included as a permanent part of your file.
Should you have any questions or concerns regarding this letter or the inspection, please write to me at the address given below.
Sincerely,
Brittany L. Garr, MPH
Branch Chief
Compliance Enforcement Branch
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Building 51, Room 5352
10903 New Hampshire Avenue
Silver Spring, MD 20993
Digitally signed by Brittany L. Garr. Date: 2026.03.19 11:03:07 -04’00’
Cc: Nu Trelle Toodle, Senior Regulatory Compliance Manager, Compliance Insight, Inc.