FDA Letter API

McKesson Corporation Headquarters

Letter data

Company
McKesson Corporation Headquarters
Recipient
Brian Tyler | CEO | McKesson Corporation Headquarters | 6555 State Hwy 161 | Irving | , | TX | 75039 | United States
Issue date
2024-05-09
Posted date
Not available
FDA office
Division of Pharmaceutical Quality Operations IV
Subject
Not available
Product
Drugs
CMS ID
565854
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER McKesson Corporation Headquarters MARCS-CMS 565854 — May 09, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 05/15/2024 Regulated Product(s) Drugs