Delivery Method: Via Email Reference #: FEI 3012369470 Product: Drugs Recipient:
Recipient Name
Mr. Richard J. Romeo
Recipient Title
President and Owner
MD Pharmaceutical Supply, LLC
P.O. Box 244
Hanover, PA 17331
United States
rromeo@mdpharmaceutical.com Issuing Office: Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
Dear Mr. Romeo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case # 637815) dated November 22, 2022.
Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Christina Alemu-Cruickshank
Compliance Officer
Division of Drug Quality I
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Content current as of:
04/17/2026
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