Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.

Immunomedics Recent FDA Inspection and Impact on their NDA Approval

After fifteen years of zero FDA enforcement activity, Immunomedics was hit hard not once, but twice in one month. The second punch was concerning enough to thrust them into the spotlight, causing their stock to be sold and their shares to plummet.