Park Infusioncare LP dba Preferred Homecare

CLOSEOUT LETTER Park Infusioncare LP dba Preferred Homecare MARCS-CMS 547494 — June 12, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 06/12/2019 Regulated Product(s) Drugs