Sewaren Innovative Pharmaceutical Packaging dba SIPP MARCS-CMS 513186 —
- Sewaren Innovative Pharmaceutical Packaging dba SIPP
- Issuing Office:
Division of Pharmaceutical Quality Operations I
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.
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office