Food and Drug Omnibus Act of 2022

Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, strategic plans, and others. FDA will post those items here as...

Ignatius P. Godoy, M.D. – 561662

Warning Letter   CBER-19-01  October 1, 2018   UPS EXPRESS MAIL & ELECTRONIC MAIL   Ignatius P. Godoy, M.D. 16660 Paramount Boulevard, Suite 206 Paramount, California 90723-5458   Dear Dr. Godoy: This Warning Letter informs you of objectionable conditions...

Wild Child WA Pty Ltd. – 589463

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Leanne Preston Recipient Title Chief Executive Officer Wild Child WA Pty Ltd. 2 Action RoadMalaga WA 6090Australia Issuing Office: Center for Drug Evaluation and Research | CDER 10903 New Hampshire...

American Botanical Pharmacy – 562180

Product: BiologicsCosmeticsDrugs Blood Products Gene Therapy Deodorant Face Paint Antibiotic Resistance Compounding Issue: Topics Premarket Public Awareness Recipient: Recipient Name Dr. Richard Schulze American Botanical Pharmacy 4114 Glencoe AveMarina del Rey, CA...

Unipharma, LLC – 585388 – 11/06/2019

Delivery Method: UPS Overnight Product: Drugs Recipient: Recipient Name Raimundo J. Santamarta Recipient Title President Unipharma, LLC 10200 NW 67th StreetTamarac, FL 33321-6404United States Issuing Office: Office of Pharmaceutical Quality Operations, Division II...