GPC Medical Ltd. – FDA 483, Jun 19, 2017

The provided text functions as an explanatory document for FDA Form 483, rather than a specific inspection report for a particular company. Dated December 3, 2019, and processed under FOIA Request # 2018-3849, the content primarily outlines the regulatory framework governing these reports. Specifically, it references Section 704(b) of the Federal Food, Drug and Cosmetic Act (21 USC 374(b)). This section mandates that an FDA officer or employee, upon completing an inspection, must provide the facility's owner, operator, or agent with a written report. This report details any conditions or practices observed that, in the inspector's judgment, suggest products (food, drugs, devices, or cosmetics) may be unwholesome, adulterated, or have been prepared or held under unsanitary conditions that could compromise health. The stated purpose of these observations is twofold: to comply with statutory requirements and to assist inspected companies in adhering to FDA regulations. The document itself does not contain specific details such as a company name, inspection dates, a list of main violations, or any company-specific required actions, as it serves as an informational preface to the FDA 483 process.