A new number: 8400!!

Current Warning Letter:

FDA found 8,400 unofficial chromatographic analyses at the Desano plant performed between 2012 and 2014. The company has acknowledged that some of those tests related to out-of-spec test results.

The FDA was also disturbed by finding many electronic logs of production deviations in a folder titled “GMP Anomalies” that had never been investigated.

Read more (external link)