ACRX Specialty Pharmacy Inc

CLOSEOUT LETTER ACRX Specialty Pharmacy Inc MARCS-CMS 609518 — July 13, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Eghomware J. Igbinovia Recipient Title Pharmacist-in-Charge/Owner ACRX Specialty Pharmacy Inc 3200 Soaring Gulls Dr STE 101 Las Vegas , NV 89129-2198 United States jerry@acrxpharmacy.com Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Igbinovia: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [case #: 609518; dated July 24, 2020]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If there is any question, please contact LCDR Rumany Penn, compliance officer, at 949-608-4409, or by email at Rumany.Penn@fda.hhs.gov. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 07/15/2022 Regulated Product(s) Drugs