- Go to http://www.fda.gov/ICECI/default.htm
- Click on “Compliance Actions and Activities”.
- In box on the left, click on “Warning Letters”. (Make sure browser is on full screen or you may not see the box on left).
- Under “Ways to View/Browse Warning Letters”, in the search box, type “Gulf Pharmaceutical”. Click “Search”.
- Read the Gulf Pharmaceutical warning letter and discuss inspectional observations 1-4. Emphasize company actions or activities that are in violation of CFR21 part 211.
- Mention what kind air flow is required in a cGMP facility and what test is used to establish the flow.
- Describe the issue with HEPA and Google what HEPA stands for.
- The Compliance Officer who wrote the warning letter is from the Office of Manufacturing and Product Quality which is part of which center in the FDA?
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