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  1. Warning Letters

CLOSEOUT LETTER

Infusion Partners, LLC MARCS-CMS 575451 —

Delivery Method:
UPS Next Day
Product:
Drugs

Recipient:
Recipient Name
Michael A. Curtis
Recipient Title
Senior Manager of Operations
Infusion Partners, LLC

4137 Boardman Canfield Rd
Ste L104
Canfield, OH 44406-8087
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States


Dear Mr. Curtis:

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 # 575451; dated March 20, 2019]. 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/
Nicholas F. Lyons
Director of Compliance
Office of Pharmaceutical Quality Operations, Division III

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