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A Report on Potential Violation of Food and Drug Administration Regulation (Case Study Sample)


Instructions from client
It’s So Delicious (ISD), Incorporated produces a line of plant-based products sold in retail grocery stores across the country. This past year, ISD began selling a new yogurt product that includes a few GRAS substances, as well as approved food additives, including carrageenan, which FDA has approved for use as a direct food additive when “used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.” In accordance with FDA’s regulations, the yogurt’s product label includes the listing of carrageenan as an ingredient. In addition to all required labeling information, the yogurt label also contains the statement "This yogurt is a good source of calcium which helps strengthen bones." FDA conducted an inspection of ISD's manufacturing facility in Philadelphia this past February. Upon approaching the facility, the FDA investigator presented proper credentials and a Notice of Inspection to the manager.
In response, the manager said, “Seriously? You guys are back already? I thought you needed a warrant if you were coming back to our facility within two years. The guy who manages our quality control has COVID and isn’t here today" and stomped off back to his office. An earlier inspection of the facility in November 2019 had resulted in the issuance of a warning that listed several deficiencies related to the facility’s conditions. During this inspection, the FDA investigator observed the production line for the yogurt. While inspecting the raw materials area of the facility, the investigator observed what appeared to be rodent urine and feces in proximity to bags holding ingredients used in the production of the yogurt. The investigator also observed several dead insects next to the refrigerators where the finished products are stored. Finally, he noted several employees coughing and not wearing face masks. The FDA investigator took photographs of these conditions and collected samples from one batch of product over the objection of the manager.
Analytical results from samples of the product taken during the inspection by FDA showed no insect contamination or other filth in the product; however, the results showed the presence of a pesticide chemical residue in excess of allowable levels. The FDA investigator also reviewed two pamphlets prepared for distribution to the stores selling the product. One pamphlet stated "adequate calcium intake throughout life, along with a healthy diet and regular exercise, builds and maintains good bone health and will reduce the risk of osteoporosis." The other pamphlet prominently featured a glass of milk next to a picture of the ISD yogurt container with the statement that “It’s So Delicious yogurt, like milk, is a good source of dietary calcium." In examining other records at the facility, the FDA investigator noted it was unclear whether these pamphlets had ever been circulated.
You have been asked to discuss any potential violations of the Federal Food, Drug, and Cosmetic Act and accompanying regulations that may be applicable to ISD to determine whether any further actions should be taken. Please discuss any additional information you need from ISD to make these determinations. Make it perfect


Following the introduction of a new product (yoghurt) by its So Delicious (ISD) company prompted an impromptu inspection by Food and Drug Administration (FDA). ISD is certified as a plant-based production entity. It had, therefore, violated the FDA's regulation by introducing the new animal-based product (yoghurt) without the agency's approval.
In an earlier inspection conducted in 2019, FDA had highlighted areas of concern that needed to be acted upon by ISD. However, the ISD had not taken any action in regards to the raised matter.
Upon arrival, the FDA investigator presented proper credentials and notice of inspection to the manager. The manager responded arrogantly, wondering why the sudden assessment, citing the absence of the firm's quality control personnel. Despite the manager's laxity, the inspection of the facility took place, and I made the following observations;

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