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Q3: Compare FDA Form 483 to an FDA "warning letter."
The intention of a Form 483 is to teach, not to punish, according to the FDA. After it conducts an inspection, the FDA prepares an internal briefing. However, it also presents a Form 483 in private to the establishment which lists all of the institution's violations of FDA regulations (Gyi et al. 2001). This is to better enable the facility to bring its standards up to code and avoid legal sanctions or receiving a publically posted warning letter on the FDA website.
In contrast, "a warning letter is issued for significant regulatory violations that require prompt and adequate corrective actions" (FDA warning letter, 2007, CIRCARE). A Form 483 is almost always issued, given that small breaches of the law are inevitable. It is designed to prevent more serious actions being required. A Form 483 elicits voluntary compliance, while if the directions of a warning letter are not obeyed, then more significant actions are likely to be undertaken in the near future, given the safety risk posed to consumer health. Consumers can also find warning notices on the web, and make decisions regarding their own health, in light of the violations.
Q4. Briefly describe four (4) enforcement actions FDA can take in response to a violation of the FD&C Act.
The FDA can seek criminal or civil penalties against both companies and individuals when its regulations are violated, depending upon the types of violations that have occurred. "Criminal prosecutions are relatively rare because the various remedies at FDA's disposal, such as recalls and seizures, and the bad publicity that violations of the Act can generate and the desire of most companies to comply with...
Thus, the FDA can seek legal remedies against the perpetuator of the violation, in criminal or civil court, or it can focus on minimizing the damage caused by the product, by demanding or suggesting a recall or seizing the product. Seizures are only likely if the product is deemed to be sufficiently hazardous to the public health and the company is likely to be noncompliant with efforts to recall and dispose of the product.
References
Employer liability. (2010). Nolo. Retrieved May 4, 2010 at http://www.nolo.com/legal-encyclopedia/article-29638.html
FDA overview. (2010). eMedicine. Retrieved May 4, 2010 at http://www.emedicinehealth.com/fda_overview/page7_em.htm
FDA warning letter. (2007). CIRCARE. Retrieved May 4, 2010 at http://www.circare.org/FOIA/warninglettertables.htm
Gyi, Felix Khin-Maung-Gyi, Paul Goebel & Matthew Whalen. (2001, September 1). What a Form 483 really means. Applied Clinical Trials. Retrieved May 4, 2001 at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=92055
2010. http://www.law.cornell.edu/supct/html/06-179.ZS.html
Retrieved May 4, 2010 at http://blogs.wsj.com/health/2008/09/19/wyeth-v-levine-the-mother-of-all-preemption-cases/tab/article/
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