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Wgu Est1 Task 2

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Company X thanks the FDA authorities for their thoughtful observations during the inspection of our manufacturing facility that concluded on 08/xx/15. Corporation X considers these observations very seriously and shall assemble a task force team to take all the crucial decisions to correct deficiencies and ensure public wellbeing. Company X shall initiate product recall on immediate basis, and shall notify consumers, employees, suppliers and regulatory bodies of product recalls as quickly as possible. The Company shall immediately stop advertising the brand. The Company shall prepare a cohesive communication plan by issuing consumer alerts, announcement ads, advising public not to take any kind of Flower Power products. The Company shall remove …show more content…

Company X shall retain a highly competent consulting firm that is qualified, and experienced in the application and implementation of cGMP activities that are important to maintain the quality and purity of products. The consulting firm after assessments of its operations, its procedures, processes, and its quality control systems shall make recommendations for improvement to address specific FDA concerns that will help us assure compliance with cGMP regulatory requirements for a long time to come. Keeping in mind the final objective to get into compliance, Company X shall take full advantage of that expert advice and will limit internal review only to remediate deficiencies outlined in the Warning Letter. Once corrections are implemented Company X shall ask FDA to re-inspect the facility and shall make plans for periodic announced and unannounced routine inspections by qualified professionals. Moreover, Company X shall plan to appoint an “advisory committee” comprising of specialists in GMP-facility management, engineering, and regulatory requirements to direct the whole

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