FDA bans API plant of India's Megafine Pharma

The FDA last week added Megafine Pharma's plant in Lakhamapur, Maharashtra, in India to its import alert list, banning all of its drug products from entering the U.S. According to Regulatory Focus, the facility received a 13-page Form 483 in May that cited it for a number of problems, many having to do with drug testing integrity. There are about 45 Indian facilities on the list. Story | More

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.