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...
[ View Full Essay]