This was a very light week for warning letters with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it here.
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
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?
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.
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.
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