Resources

Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter this week based […]

We’re back after a week off and covering all warning letters from the last two weeks.Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs.There is also one warning letter to a cell therapy manufacturer. Although we do not routinely cover enforcement actions by the […]

Pleasanton, CA | September 16, 2019: Redica Systems, a leader in government intelligence and analytics for all FDA-regulated industries, today announced that it has named Jonathan Rochez as VP of Engineering at Redica Systems. Jonathan, with over 18 years of experience in software development and management including work across web development, desktop app development, and […]

Bloomberg: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.An FDA quality-control nightmare reveals how impurities end up in America’s blood pressure pills. Read the full article here. Original story: https://www.bloomberg.com/news/features/2019-09-12/how-carcinogen-tainted-generic-drug-valsartan-got-past-the-fda

This week, there were two warning letters issued to pharmaceutical firms. But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program. I missed this EIR when it published Aug 15, 2019 on the FDA ORA Reading Room.This […]

Pleasanton, CA | August 30, 2019: Please join us in officially welcoming Jane Wastl to Govzilla. Several months ago, Jane joined our panel of contributing experts, lending her expertise to our product development team as well as our publishing department.As of August 2019, she accepted a position as a Senior GMP Quality Expert. “I’m pleased […]

Pleasanton, CA | August 29, 2019: Govzilla, a global leader in FDA intelligence and analytics, announced the addition of Jerry Chapman as Senior GMP Quality Expert — further filling out its team of industry experts. “I am incredibly excited for the addition of industry expert Jerry Chapman to the Govzilla team,” says Michael de la […]

UPDATE: Due to popular demand, we’ve added a second session! You can now to attend on Thursday, September 19th at 1PM ET/10AM PT or on Tuesday, October 1st at 1PM ET/10AM PT. Choose the date that works best for you and reserve your spot today before both sessions fill up! FDA-regulated firms and affiliated companies face an […]

This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer.The first one issued to Deva Holdings addresses severe penicillin cross-contamination. DRUGS | Deva Holding AS Cerkezkoy Subesi Deva Holding AS Cerkezkoy Subesi (Istanbul, Turkey) received a warning […]

FDA recently published the Office of Compliance Annual Report for Calendar Year 2018. Their stated mission is “To shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions.” The Annual Report describes how they have fulfilled that mission in calendar year 2018, and we cover some of those activities […]