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  5. Walfer Corporation dba Wallace Pharmacy - 611017 - 09/20/2022
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CLOSEOUT LETTER

Walfer Corporation dba Wallace Pharmacy MARCS-CMS 611017 —

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

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