DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration New Jersey District Office Central Region Waterview Corporate Center 10 Waterview Blvd. 3 rd Floor Parsippany, New Jersey 07054 Telephone: (973) 331-49

UNITED PARCEL SERVICE

Daron G. Evans, President & CEO

Edge, New Jersey 07661-1947

Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning

Letter (15-NWJ-05), dated May 27, 2015. Based on our evaluation, it appears that you have addressed the violation(s)

contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and

sustainability of these corrections.

letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance

with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency

expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude

any future regulatory action should violations be observed during a subsequent inspection or through other means.