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  5. Park Infusioncare LP dba Preferred Homecare - 547494 - 06/12/2019
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CLOSEOUT LETTER

Park Infusioncare LP dba Preferred Homecare MARCS-CMS 547494 —

Product:
Drugs
Recipient:
Recipient Name
Mr. Robert Fahlman
Park Infusioncare LP dba Preferred Homecare

4601 East Hilton Ave., Suite 100
Phoenix, AZ 85034
United States

Issuing Office:
Dallas District Office

United States

June 12, 2019

Case #547494

VIA UPS EXPRESS

Robert Fahlman, Chief Executive Officer
Preferred Homecare (Corporate Office)
4601 East Hilton Ave., Suite 100
Phoenix, Arizona 85034-6406

Mr. Fahlman:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (Case #547494), dated March 1, 2018. We acknowledge that your firm, located at 13621 Inwood Road, Suite 420, Dallas, Texas 75244-4654, was sold to Coram CVS Specialty Infusion Services and closed for business on March 9, 2018.

If you decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to beginning drug production. You are expected to take all necessary steps to assure 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.

If you have any questions regarding this letter, please contact me at (214) 253-5288 or via e-mail at John.Diehl@fda.hhs.gov.

Sincerely,
/S/

CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division 2

 
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