BLS465_Final Project

BLS465_Final Project - When the FDA notified us that their...

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When the FDA notified us that their research suggested our new vitamin, Healthy MAX appeared to be causing gastrointestinal problems we immediately brought the issue to our head chemist. After he claimed the complaints were not related to the drug Healthy MAX we decided to do further research to ensure consumer safety. We looked into the manufacturing process considering last year’s report was done my internal staff. While the audit presented a “stellar” report, G-BioSport felt that it was necessary to bring in external auditors and FDA inspectors to double check our work. The vitamin is manufactured by two subcontractors, one of which is in the United States and the other which is abroad, both are overseen by the Miami Division of G- BioSport. During the past year there was a storm that affected one of the plants that produced the vitamin. Before the FDA was brought in there appeared to be no evidence that the storm affected the manufacturing process of Healthy MAX. Considering the severity of the situation G-BioSport has decided to do a firm initiated recall with the supervision of the FDA. Working closely with the FDA and external auditors G- BioSport has recalled the product at the wholesale, retail, consumer, and user levels. The source of the problem has been traced to imported raw materials that contain the deadly toxin, arsenic. In addition to contaminated raw materials, the equipment in the East Plant does not meet the cGMP standards due to mold from the severe weather. To correct these issues G-BioSport must improve the quality system controls they currently have in place. The plan to implement these new standards involves training employees more effectively, communicating higher standards with vendors, and creating a disaster plan. Utilizing the FDA’s expertise G-BioSport will continue oversight in both plants until the situation has been completely resolved. In efforts to evaluate our operations, we have decided to temporarily shut down the operations of both manufacturing plants. Using oversight from the FDA, G-BioSport will 1
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identify all operation defaults and continue to work closely with the FDA to successfully continue operations. Through effectively managing resources from our company insurance policy which requires sub-contractors to carry $100 million each in Product Liability Insurance, requiring additional internal and external audits, and correcting our plant operations, G-BioSport hopes to continue operations in the near future. In addressing the 15 complaints from consumers experiencing nausea associated with use of Healthy MAX, we have decided to use the advice of FDA and recall all Healthy MAX from the wholesale, retail, consumer, and user levels in order to render any potential side effects. To respond to consumers that are currently taking Healthy MAX but have not experienced any illness, they will be required to contact a G-BioSport Consumer Healthcare associate. In addition, G-BioSport will have an up to date website to aid consumers and the public of issues
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This note was uploaded on 11/15/2011 for the course BLS 465 taught by Professor Herron during the Fall '11 term at Miami University.

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BLS465_Final Project - When the FDA notified us that their...

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