FDA 483 - Institute of Regenerative and Cellular Medicine - October 19, 2021

The provided document outlines the fundamental purpose and regulatory framework of an FDA Form 483, a report issued by the U.S. Food and Drug Administration. This form serves to document objectionable conditions or practices observed during an inspection of an establishment, such as a factory or warehouse. Its authority stems from Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)). Upon concluding an inspection, the inspecting officer is mandated to present this written report to the establishment's owner, operator, or agent. The report details observations that, in the inspector's judgment, suggest products – including food, drugs, devices, or cosmetics – either contain filthy, putrid, or decomposed substances, or have been manufactured, packaged, or stored under unsanitary conditions. Such conditions could lead to contamination or render products harmful to health. The primary objective of the FDA 483 is twofold: to formally report non-compliant conditions and to guide inspected entities toward adherence with applicable acts and regulations. A copy of this report is subsequently forwarded to the Secretary, ensuring official record-keeping of the findings. This process underscores the FDA's commitment to public health and product safety standards.