In the world of FDA-regulated industries, few events evoke more anxiety than the arrival of an FDA Consumer Safety Officer/Investigator for an unannounced inspection. For many facilities, the most dreaded outcome of such an inspection is the issuance of a Form FDA 483 – Inspectional Observations. This form is the FDA’s way of communicating to the world that the facility has been found to have one or more potential violations of the Federal Food, Drug, and Cosmetic Act and may not be operating in full compliance with current Good Manufacturing Practices (cGMP). We look forward to hearing about you. Please get started by emailing us at sales@biotech.com or using our contact form.