FDA 483 - CooperVision Lens Care Limited - November 12, 2018

This FDA 483 document, released under FOIA request 2018-10345 on October 19, 2020, primarily outlines the statutory basis and purpose of an FDA Form 483 observation report. It does not detail specific inspection findings for a particular company or provide inspection dates. The document explains that Form 483 observations are reported pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act (21 USC 374(b)). This section mandates that an inspecting officer report any observed conditions or practices indicating that a product (food, drug, device, or cosmetic) is adulterated, decomposed, or has been prepared or held under insanitary conditions. The form serves to inform firms of objectionable conditions and assist them in complying with FDA regulations. Specific violations, company name, and required actions for a particular entity are absent from the provided text.