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	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