Hi ruchi ^^, instructions are in the word doc, thank you ;)

Ruchi instructions on bottom, only answer both questions in one page, thank you ^^. Attach is case u should use. Johnson & Johnson (J & J) enjoyed a halo effect for many decades after their iconic precautionary recall of Tylenol capsules in 1982, which was greatly facilitated by the famous Johnson & Johnson Credo1 that stipulated patient well-being to be paramount in importance. But that halo has now been lost due to the events that led to the company's recall of children's Tylenol and other children's medicines in 2009 and 2010. On April 30, 2010, J & J's McNeil Consumer Healthcare, LLC (McNeil Division) \"recalled some 50 children's versions of non-prescription drugs, including Tylenol, Motrin and Benadryl.\"2 In total, 136 million bottles of liquid were involved.3 This was the fourth recall in seven months. Earlier recalls included: November 2009five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap due to reports of an unusual moldy, musty, or mildew-like odor that led to some cases of nausea, stomach pain, vomiting, and diarrhea. December 2009November recall expanded to all lots of the product. January 2010an undisclosed number of containers of Tylenol, Motrin, and over-the-counter drugs after consumers complained of feeling sick from an unusual odor.4 The McNeil Division had four plants including those at Fort Washington, Pennsylvania (operated as a joint venture with Merck & Co.), and Las Piedras, Puerto Rico. J & J shut down the Fort Washington plant in April 2010 just before an unannounced inspection from the U.S. Food and Drug Administration (FDA). But according to the FDA Statement to the Committee of Oversight and Government Reform of the U.S. House of Representatives on May, 21, 2010,5 FDA concerns over the company's manufacturing processes began several years earlier. The FDA is responsible for ensuring that companies manufacture and distribute drugs that are safe for consumers in accordance with current Good Manufacturing Processes (cGMP) that cover minimum requirements for methods, facilities, and controls used in the manufacturing and packaging of the products. According to the FDA Report: Under the cGMP regulations, each manufacturer sets specifications for its own products for such factors as potency, stability and purity, and puts in place a quality system that ensures those specifications are met. Critical to the cGMP process is that a company must meet its own standards. A violation of cGMP does not necessarily mean that a product is hazardous to the public. It does indicate, however, a breakdown in a manufacturer's quality system and is an indication that a company needs to take effective steps to fix the problem promptly. FDA inspects facilities to ensure compliance with cGMP standards. These inspections occur on average for domestic facilities every two to three years. We increase the frequency of inspections for facilities when warranted by past problems or by products that are difficult to manufacture or are especially high risk.6 Prior to 2009, the FDA inspections had noted several problems with \"laboratory controls, equipment cleaning processes, and a failure to investigate identified problems,\"7 but these were \"generally fixed.\"8 During 2009, the FDA identified several more problems including: At the Fort Washington plantfailure of McNeil to meet its own standards for an ingredient, microcrystalline cellulose, that required it to use input with no gram-negative bacteria. The supplier found that some partial lots of a master batch did contain a gram-negative bacteria known as B. cepacia, and although the lots McNeil used did not test positive, none of the partial lots from this batch should have been used. Although the FDA concluded the risk to the public was remote, 8 million bottles of finished product were recalled in August. At the Las Piedras, Puerto Rico plantFDA urging resulted in McNeil investigating year-old complaints about products from the plant having a musty odor, and finding that it was attributable to a pesticide (2, 4, 6-Tribromoanisole or TBA) used on wooden storage pallets for empty medication bottles. Again the risk to the public was thought not to be serious for long-term health problems because of the small quantities transferred, although exposure could include nausea, stomach pain, vomiting, and diarrhea. In this case, McNeil should have reported the problem to the FDA within 3 days of the first reports. The FDA also reported that little is really known about the chemical TBA. These incidents led the FDA to send a warning letter on January 15, 2010, to McNeil, but upper management at neither McNeil nor J & J responded to assure timely investigation and resolution of the issues raised. At about the same time, the FDA investigated a report of the death of a 6-year-old girl but could not relate her death to any of the company's medications. On February 19, 2010, the FDA called senior officials from McNeill and its parent company J & J to a meeting to give them notice about the patterns of violation of cGMP standards, recent recalls and warning letters, and failure to report information to the FDA in a timely manner. At the meeting, the FDA were told that structural changes, new management, and a new consultant were to be put in place to deal with these problems. The FDA investigators returned to the Fort Washington plant in April 2010 to find that just days before it had been shut down because particulates including acetaminophen, cellulose, nickel, and chromium had been found in several liquid medications. Moreover, bacteria and particulate counts exceeded the company's cGMP standards, and Tylenol in too high a strength had been manufactured, but not sold. Although the particulates were small enough to pass out through the intestinal tract without harm, there was justifiable concern over the lack of appropriate safety-conscious culture and safeguards in place. The FDA Report concluded by indicating that they did not think the public had been subject to any serious health risk, but they were concerned and would be working with management to rectify this issue raised. They were also considering such enforcement actions as seizure, injunction, or criminal penalties. In addition, the FDA stated that they had learned several lessons that would factor into a revision of FDA inspection procedures, linkage of findings at on company site to another such site, and recall procedures. On July 21, 2010, the FDA released a report on its investigations at another of J & J's plantsthis one located in Lancaster PAthat indicated: a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping.9 The report listed 12 types of violations, including the following: \"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality and purity.\" Procedures to prevent \"objectionable microorganisms\" from getting into medicines appear not to have been followed. \"Deviations from written test procedures are not justified.\" Staff were not following up \"to determine the causes for repeated mix-up of tablets.\" Written procedures for cleaning and maintenance did not have enough detail about the methods, equipment and materials to be used. The plant did not have recent drug production and quality control records readily available to the inspectors, as is required. Samples of drug products taken to determine if they met written specifications were not properly identified. There was no preventive maintenance program for at least five types of complex manufacturing or testing equipment.10 According to the Associated Press, on the day the report was released, J & J's stock dropped 2.5 percent to $57.12. Estimates of the cost of recalls and the shutdown of the Fort Washington plant were $600 million in 2010. The Fort Washington plant manager had been fired and 300-400 workers had lost their jobs.11 Questions 1. Who was really to blame for the lax procedures found? 2. How should this situation be remedied? Requirements and Grading Rubric For Case Studies I. Requirements for Case Study Report For each case study assigned, write a one page (double spaced) summary of the most relevant facts of the case studies assigned for a certain week. Don't write more than one page, as there should be a careful consideration of what is most important about the case Your summary should include the following points: Present the facts most relevant to the ethical issues Answer two of the questions from the list presented below which would assist in understanding the ethical issues of the case or that might lead to a resolution of the ethical problem. Questions of fact Questions of interpretations Questions of analysis Questions of synthesis Questions of evaluation Questions of application II. Grading Rubric Format Typed Double-spaced Title Page with Assignment title, Student Name, Course Name, Week # and Date Reference Page Grading Rubric Documentation and Formatting - 5% A quality paper will include the items from format above Organization & Cohesiveness - 15% A quality paper will include an introduction stating the purpose/intent of the paper (5%). The body of the content will be derived from the assignment itself, and will be properly subdivided into sections based upon what the paper must address (5%). In a quality paper, the conclusion will summarize the previously presented content (5%). Editing - 10% A quality paper will be free of any spelling, punctuation, or grammatical errors. Sentences and paragraphs will be clear, concise, and factually correct. Content - 70% A quality paper will have significant scope and depth of analysis/research to support any statements. Relevant illustration or examples are encouraged. A quality paper will employ sound use of reasoning and logic to reinforce conclusion, and opinions