The department said Aug. 19 the drugmaker violated the Federal Food, Drug, and Cosmetic Act by “failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient and failing to fully investigate the root cause of such contamination.”
The FDA inspected the facility in 2011, 2014, 2016, 2019 and 2021. In 2017, the agency issued a warning letter.
Morton Grove Pharmaceuticals will stop producing, labeling and distributing its “adulterated drugs,” according to the Justice Department. The company must also destroy all drugs in the facility except for medically necessary products.
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