Govzilla and FOI Services announced Tuesday, April 16th, 2019 the beginning of their official partnership that integrates FOI Services’ unique and vast dataset with Govzilla’s innovative analytics tools to help solve regulatory intelligence problems. FDA regulated industries' need for immediate access to enforcement documents is growing as more companies expand their markets and supply chains across the globe. The ability [...]
We cover two warning letters to compounding pharmacies. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago.
CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?
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.
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.