Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years. In addition, there were another two to drug product manufacturers and one to an in vitro diagnostics firm.
We cover four warning letters from last week including two to pharmaceutical firms and two to compounding facilities. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago.
Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.
We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies.
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.
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.
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.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.