Sewaren Innovative Pharmaceutical Packaging dba SIPP

CLOSEOUT LETTER Sewaren Innovative Pharmaceutical Packaging dba SIPP MARCS-CMS 513186 — February 01, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Sewaren Innovative Pharmaceutical Packaging dba SIPP 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 February 1, 2018 VIA UPS NEXT DAY AIR Hank Incognito, Owner Sewaren Innovative Pharmaceutical Packaging dba SIPP 994 Rahway Avenue Suite 1 Avenel, NJ 07001-1946 Dear Mr. Incognito: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s May 31, 2017 response to our warning letter WL # 17-NWJ-02 dated May 22, 2017. We acknowledge that your firm ceased drug production at this facility. 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/ Diana Amador Toro Division Director/OPQ Division 1 New Jersey District Office Content current as of: 02/14/2018