Walfer Corporation dba Wallace Pharmacy MARCS-CMS 611017 —
- Delivery Method:
- Via Email
Recipient NameWayne Wallace
- Walfer Corporation dba Wallace Pharmacy
3524 B Tamiami Trail
Port Charlotte, FL 33952-8100
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
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.
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
cc: Via Electronic Mail
Jonathan Meltz, Esq.
CHAPMAN LAW GROUP
1001 Brickell Bay Dr., Suite 1714
Miami, Florida 33131