Walfer Corporation dba Wallace Pharmacy

CLOSEOUT LETTER Walfer Corporation dba Wallace Pharmacy MARCS-CMS 611017 — September 20, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Wayne Wallace Recipient Title Owner Walfer Corporation dba Wallace Pharmacy 3524 B Tamiami Trail Port Charlotte , FL 33952-8100 United States Wallacepharmacy85@gmail.com Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Dear Mr. Wallace: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS Case #611017), dated September 17, 2021. We acknowledge that your firm no longer produces sterile drug products. 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. Sincerely, /S/ Mark Rivero Acting Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II cc: Via Electronic Mail Jonathan Meltz, Esq. CHAPMAN LAW GROUP 1001 Brickell Bay Dr., Suite 1714 Miami, Florida 33131 JMeltz@ChapmanLawGroup.com Content current as of: 09/26/2022 Regulated Product(s) Drugs