FDA Letter API

Infusion Partners, LLC

Letter data

Company
Infusion Partners, LLC
Recipient
Michael A. Curtis | Senior Manager of Operations | Infusion Partners, LLC | 4137 Boardman Canfield Rd | Ste L104 | Canfield | , | OH | 44406-8087 | United States
Issue date
2022-01-26
Posted date
Not available
FDA office
Division of Pharmaceutical Quality Operations III
Subject
Not available
Product
Drugs
CMS ID
575451
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER Infusion Partners, LLC MARCS-CMS 575451 — January 26, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/11/2022 Regulated Product(s) Drugs