HW validation

Search the warning letters below for “validation” and summarize the violations around that topic.  You can include a brief introduction on the violative products or company products. 

1. Go to: https://www.fda.gov/default.htm

Under “Recalls and Alerts” click on “Warning Letters”

Under “Ways to View/Browse Warning Letters” paste “CGMP/Finished Pharmaceuticals” in the search box, and click the search button.

In the results table, find the warning letter for Gulf Pharmaceutical Industries.

2. Go to: https://www.fda.gov/default.htm

Under “Recalls and Alerts” click on “Warning Letters”

Near the top of the page, look for “Archived Warning Letters” and choose 2010.

Below the results table, click on page 30. You should see the warning letter for Sunrise Pharmaceutical.