Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

McKesson San Francisco, CA (2/7): FDA inspected the company 6/2018 which resulted in the first Warning Letter under the Drug Supply Chain Security Act. The inspection cited McKesson for violations highlighted by a “concerning tampering incident that involved opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder, and high blood pressure.” The company was also cited for failing to respond to illegitimate product notifications as required, including identifying all illegitimate product subject to such notifications in the company’s possession or control and quarantining such product. And it failed to keep, for not less than six years, records of the investigation of suspect product and the disposition of illegitimate product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631088.htm