Posted: October 3rd, 2022

You will be graded on the following (2 points each): -does the selected warning letter meet the criteria outlined above?

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Please go to the FDA warning letter database located here: https://www.fda.gov/inspections- compliance-enforcement-and-criminal-investigations/compliance-actions-and- activities/warning-letters In the “subject” section, you will find letters that are categorized as “GMP/adulterated”, “GMP/drug product/adulterated”, “API/adulterated,” etc. Read through warning letters pertaining to GMP topics for drugs, biologics, or APIs. DO NOT select warning letters for dietary substances, veterinary products including animal feed, misbranded products, unapproved new drug products, or tobacco products. Your topic will be MANUFACTURING INVESTIGATIONS, you must find a warning letter that discusses that topic (for example, OOS investigations). Prepare a short slide deck (5-10 slides, depending on the length of the warning letter) that includes the following: 1. Company name and location (you can include a few words about the company, but no more than one slide) 2. A summary of the observation that covers your topic, including the following: Type of product, if known (sterile injectable? Solid oral dose? etc.) A short description of the violation, including the regulation cited What was lacking in the company’s response? 3. A brief overview of the other topics covered in the warning letter, and the regulations that were cited. 4. A discussion on why you think the FDA is concerned about the products coming from the facility, based on the observations and language in the warning letter Please post your warning letter on Sunday of the week you are assigned, and don’t forget to monitor the discussion board during the week so that you can respond to the comments. You will be graded on the following (2 points each): -Does the selected warning letter meet the criteria outlined above? -Was the assigned observation described accurately? -Did the slides accurately describe what the FDA perceived as lacking about the 483 response? -Were other observations included with a brief description, including the regulations cited? -Is the description of the FDA’s concern about the products coming from the facility clear and cogent? feel free to use any amount of course if necessary

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