HW 10

1. Go to http://www.fda.gov/ICECI/default.htm

2. Click on “Compliance Actions and Activities”.

3. 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).

4. Under “Ways to View/Browse Warning Letters”, in the search box, type “Gulf Pharmaceutical”. Click “Search”.

5. 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.

a. Mention what kind air flow is required in a cGMP facility and what test is used to establish the flow.

b. Describe the issue with HEPA and Google what HEPA stands for.

6. 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?

1 page minimum, Arial 11 pts, 1.15 spacing. No reference section needed.