- Delivery Method:
- VIA EMAIL CONFIRMED DELIVERY
Recipient NameEghomware J. Igbinovia
- ACRX Specialty Pharmacy Inc
3200 Soaring Gulls Dr
Las Vegas, NV 89129-2198
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV