Inspections, Compliance, Enforcement, and Criminal Investigations

Wyeth Lederle S.p.A - Close Out Letter 9/18/17



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10903 New Hampshire Avenue
Silver Spring, MD 20993 

September 18, 2017

Mr. Giuseppe Campobasso
Wyeth Lederle S.r.l
Via Franco Gorgone
6/A- Zona Industriale
95121 Catania, Italy

Reference: FEI 3002806766

Dear Mr. Campobasso:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-13-10 dated March 27, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This 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.

LaKeesha M. Foster
Consumer Safety Officer
Global Compliance Branch 4

Page Last Updated: 09/21/2017
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