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  1. Warning Letters

CLOSEOUT LETTER

McKesson Corporation Headquarters MARCS-CMS 565854 —

Delivery Method:
Via Electronic Mail Return Confirmation Requested
Product:
Drugs

Recipient:
Recipient Name
Brian Tyler
Recipient Title
CEO
McKesson Corporation Headquarters

6555 State Hwy 161
Irving, TX 75039
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Secondary Issuing Offices

United States


Dear Mr. Tyler:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #565854 dated February 7, 2019]. Based on our evaluation, it appears you have addressed the violations contained in the 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.

If you have questions regarding the contents of this letter, you may contact Rebecca Asente, Compliance Officer via (504) 846-6104 or via Rebecca.Asente@fda.hhs.gov.


Sincerely,
/S/
Ronda R.
Ronda Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II

 
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