California Drugmaker Rapped for Data Backups, Other Violations

The FDA cited a Huntington Beach, Calif., drug manufacturer for four violations at its facility, including a lack of data backups.

An agency inspection of the Calmo Manufacturing’s facility found that the firm had not backed up software-generated electronic data to an external hard drive since 2017, and it lacked a  written procedure specifying how often data should be backed up.

In 2018, the firm shut down its long-term and accelerated stability chambers for more than two weeks for maintenance, but failed to file a deviation report for the event. The stability chambers were not requalified after being shut down and the company had no written SOP describing when they should be requalified, the agency said.