4 Open ended problem: Go to www.fda.gov and search for FDA warning letters to Di

Question

4 Open ended problem: Go to www.fda.gov and search for FDA warning letters to Dietary supplements. Your task is to: Research what Observation 483s and warning letters are from FDA standpoint and provide the difference Pick an FDA warning letter related to a Dietary Supplement Company and attach the link to your homework. Describe, in your own words, why the organization received the warning letter, and what could have been done to prevent this quality issue. You may need to do some research on the federal code of regulations 21.CFR.111 to understand what the issues in quality were, and what they could have done to mitigate/prevent the occurrence of the issue. a. b. c.

Explanation / Answer

The dietary supplement company received warning letters because of FDA laboratory tests revealed an variety of active ingredient in products manafuctured and marketed as dietary supplements. They contain ingredients of anticoagulant, anticonvulsant, HMG CoA reductase inhibitor, NSAID and beta blocker. They also identified products marketed as dietary supplements that contains pharmaceutical contents.

These products are illegal and unapproved by the FDA and these ingredients are deceptively labelled ingredients. They cause risks to the consumers but undermine confidence of the company.

In order to protect the people from these harmful ingredients present in the dietary supplements, FDA must identify and test the products are already in the market. These tests will require an investment of time and resources.

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