trending Market Intelligence /marketintelligence/en/news-insights/trending/pu3yquhz_fxcdubrbzkdbw2 content esgSubNav
In This List

US FDA records violations at Alkem's manufacturing plants in India, US

Blog

Baird Research is Now Exclusively Available in S&P Global’s Aftermarket Research Collection

Blog

Japan M&A By the Numbers: Q4 2023

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity


US FDA records violations at Alkem's manufacturing plants in India, US

Alkem Laboratories Ltd. said the U.S. Food and Drug Administration recorded 13 violations at its manufacturing facilities in India and the U.S.

The regulator issued a Form 483 following an inspection at the company's plants in Daman, India, and St. Louis.

A Form 483 is issued when investigators observe any conditions or practices that may have violated the Food Drug and Cosmetic Act and could later pose health hazards to consumers.

The company has already submitted a corrective and preventive action plan to the FDA for its U.S.-based facility.

Alkem plans to submit a response for the Indian facility in the future.