RECENT POSTS

Post by Amy Filbin | June 24, 2019

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…We are looking for an Account Manager to create long-term, trusting relationships with our customers. The Account Manager’s primary role is to provide our customers with the support they need to be successful in their jobs using the FDAzilla platform.

FDA Form 483s - May
Post by Jessica Strmiska | June 20, 2019

May 2019 | New FDA 483s

In May of 2019, we added 262 FDA 483s to our database of 27,500+ FDA inspection documents.

WWL061819
Post by Barbara W. Unger | June 18, 2019

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.

10-Ways-to-Prepare-for-a-GMP-Inspection
Post by Barbara W. Unger | June 13, 2019

10 Ways for Small and Virtual Companies to Prepare for a GMP Inspection

Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.

WWL061119
Post by Barbara W. Unger | June 11, 2019

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

Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.

FDA Form 483s - April
Post by Jessica Strmiska | June 6, 2019

April 2019 | New FDA 483s

In April of 2019, we added 226 483s to our database of 27,500+ FDA inspection documents.

WWL060419
Post by Barbara W. Unger | June 4, 2019

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

Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.

CDER DI Part 3
Post by Michael de la Torre | May 30, 2019

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

Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.

WWL052819
Post by Barbara W. Unger | May 28, 2019

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 cites numerous repeat observations from previous inspections.