FDA 483 - Pharmasol Corporation - August 20, 2018

The U.S. Food and Drug Administration (FDA) conducted an inspection of Pharmasol Corporation, a human drug manufacturer located in South Easton, MA. The inspection spanned from July 23, 2018, to August 20, 2018. Following this assessment, an FDA Form 483 was issued to President Marc L. Badia on September 4, 2018. This document detailed nine distinct inspectional observations concerning conditions and practices found at the facility. While the specific nature of these observations is redacted within the provided text, a Form 483 generally indicates potential deviations from current manufacturing practices or other regulatory requirements. These findings are reported under the authority of Section 704(b) of the Federal Food, Drug and Cosmetic Act, which is designed to identify circumstances where a drug product might be considered adulterated, such as being prepared or held under insanitary conditions, or consisting of filthy or decomposed substances. The issuance of an FDA Form 483 requires Pharmasol Corporation to promptly investigate and formally respond to each observation, outlining corrective actions taken or planned to bring their operations into full compliance with federal health and safety standards for human drug manufacturing.