We’re Hiring! Account Manager Needed

A quick note to say: Govzilla is hiring! We’re looking for an account manager to report to the Head of Sales. This is a full-time position based anywhere you are. Here are the details… Job brief We are looking for an Account Manager to create long-term, trusting relationships with our customers. The Account Manager’s primary […]

May 2019 | New FDA 483s

In May of 2019, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Post no longer available

Week of June 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This was a busy week in contrast to the past two weeks in terms of posted warning letters. Seven drug warning letters and one device warning letter were posted this week. DRUGS | Glint Cosmetics Pvt. Ltd Glint Cosmetics Pvt. Ltd (Maharashtra, India) received a warning letter on May 31, 2019 based on the outcome […]

Week of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

It was a slow week for warning letters with just two new published.Both were issued to drug manufacturers. DRUGS | Kingston Pharma LLC Kingston Pharma LLC (Massena, NY) received a warning letter based on the outcome of an inspection ending December 10, 2018.The firm manufactures over-the-counter (OTC) drugs. FDA recommends the firm hire consultants to […]

April 2019 | New FDA 483s

In April of 2019, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Post no longer available

Medscape | June 6, 2019

‘Scary World’ of Generic Drug Manufacturing, Revealed Read full article here. Medscape Article: ‘Scary World’ of Generic Drug Manufacturing, Revealed

Week of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA’s website update makes warning letters a bit more difficult to monitor because they no longer list the date the letter is posted on the website. The letters continue to be listed, however, in chronological order, so if an older letter is […]

Data Integrity Trends in 483s and Warning Letters: Part 3

This is the last part in a series of three posts; get up to speed with parts one and two. Now that we’ve reviewed top-level data integrity (DI) trends and what DI keywords the FDA is citing in 483 Observations, let’s look at DI keywords cited in warning letters. Does the FDA cite the same […]

Week of May 19th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA’s website update makes warning letters a bit more difficult to monitor because they no longer list the date the letter is posted on the website. The letters continue to be listed, however, in chronological order, so if an older letter is […]

Week of May 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement included five warning letters to either homeopathic or OTC firms continuing the FDA’s focus in this area that we saw begin in 2017 and really ramp up in 2018. Fundamental GMPs seem to be missing. It appears that FDA has implemented enforcement against both the product owner and the contract manufacturer in this group. This, in my […]
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