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.
Here we look at the interval between inspection and issuance of warning letters and the interval between inspection and issuance of import alerts for FY2018 drug GMP warning letters.
There were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on OTC and contract manufacturers.
We cover warning letters outside the U.S., enforcement of OTC and contract manufacturers/laboratories, import alerts associated with warning letters and data integrity deficiencies.
This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics company. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment.
This week, enforcement was busy with a GLP warning letter, warning letters to an API manufacturer, a pharmaceutical firm, a couple of compounding pharmacies, and a device firm.
We cover four recent warning letters, including one to a drug manufacturer, one to a distributor, and two to medical device firms.
The global supply chain for drug products has become increasingly more complicated, and as such has expanded the scope of sites FDA must routinely inspect.
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.