Resources

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 […]

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’. One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products […]

FDA posted seven warning letters this week, among which was one to the manufacturer of a dietary supplement and one to a finish pharmaceutical manufacturer. We cover the later below. In addition, FDA continues their enforcement against those who sell flavored liquid tobacco products by issuing four warning letters notifying the companies that forty-four products do not […]

FDA posted five warning letters this week, including several from the Center for Tobacco. None are drug or device GMP warning letters. Now for the interesting part, two warning letters that we cover below were identified as posted on July 23rd. I think this may not be the case because I follow these so closely. So, for any of […]

This week FDA posted three GMP warning letters to drug facilities. We also cover a warning letter to an unapproved, misbranded new drug because of the product category. UNAPPROVED NEW DRUGS | Curaleaf, Inc Curaleaf, Inc (Wakefield, MA) received a warning letter based on evaluation of information on the firm’s website. We generally do not cover warning […]