Enclara Pharmacia Inc

CLOSEOUT LETTER Enclara Pharmacia Inc MARCS-CMS 513262 — January 19, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Enclara Pharmacia Inc United States Issuing Office: United States Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 CERTIFIED MAIL RETURN RECEIPT REQUESTED January 19, 2018 John R. Loxterman Vice President, Chief Compliance Officer Enclara Pharmacia, Inc. 512 Elmwood Avenue Sharon Hill, PA 19079-1014 Dear Mr. Loxterman: This letter acknowledges receipt of your letter dated April 11, 2017, in which you responded to FDA’s warning letter (ref: WL# 17-PHI-09) dated March 29, 2017. We acknowledge your statement that your firm no longer produces sterile drug products. Therefore, it appears that you have adequately addressed the violations contained in this warning letter. We note that in your response you stated that the warning letter alleged that your facility was deficient with regards to current good manufacturing practice (CGMP) requirements. As our letter states, the conditions observed during our inspection and described in the warning letter are violations of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act. Regardless of whether your firm meets the conditions of section 503A and qualifies for the exemption from compliance with CGMP requirements, drug products prepared, packed, or held under insanitary conditions are adulterated. For additional information on insanitary conditions, we direct you to our draft guidance, Insanitary Conditions at Compounding Facilities, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf . This guidance, if finalized, would provide additional guidance to pharmacies and State regulatory agencies in identifying insanitary conditions in compounding facilities. 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. Sincerely, /S/ Yvette Johnson Compliance Officer – PHRM1- CB Content current as of: 01/23/2018