McKesson Corporation Headquarters 2/7/19 – FDA Warning Letter, Feb 12, 2019

This FDA Warning Letter, dated February 12, 2019, was issued to a facility located at 19701 Fairchild Rd, Irvine, CA 92612, with the corporate address listed as One Post Street, San Francisco, CA 94104. The letter indicates that an inspection was conducted, revealing significant violations of the Federal Food, Drug, and Cosmetic Act.

The specific violations and deficiencies are not detailed in the provided excerpt but are implied to be significant enough to warrant a Warning Letter. Such letters typically outline deviations from Good Manufacturing Practices (GMP) or other regulatory requirements for products under FDA jurisdiction. The issuance of a Warning Letter signifies that the FDA has found evidence of non-compliance that requires prompt corrective action.

The letter serves as official notification of these violations and requires the company to implement specific corrective actions to address the identified issues and prevent recurrence. While the exact required actions and timelines are not specified in this excerpt, Warning Letters generally mandate a written response within 15 working days detailing the steps taken or planned to correct the violations and a timeline for completion. Failure to adequately address the violations can lead to further enforcement actions, including product seizure, injunctions, and civil penalties. The letter implies a need for improvements in the company's quality system and overall compliance with FDA regulations.