4 ms·
From the article: "This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manu
by magneticnorth 2y ago
From the article: "This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manufacturing processes that prevent defective drugs from winding up in American medicine cabinets."
In the case of potassium pills, they should be quality-testing the extended release mechanism. It's possible an inspector wouldn't be able to catch that their quality testing is shoddy or non-existent in every specific case, but if they show up and see a pattern of bad manufacturing processes, that's important to act on.