FDA inspections, 483s and Warning Letters are part of the FDA’s regulatory process to ensure that products created by manufacturers are safe for consumers. FDA inspections involve visiting a manufacturer’s facility to evaluate if they are in compliance with FDA regulations. The FDA may issue 483s if they find any non-compliances during their inspection. A 483 is a list of items that need to be corrected within 15 days or else further action will be taken by the FDA. If the FDA finds serious violations, such as failure to properly follow Good Manufacturing Practices (GMPs), they might issue a Warning Letter instead of a 483.
A Warning Letter is more serious than a 483 and must also include corrective actions that the manufacturer needs to take in order to comply with FDA regulations. If the FDA finds that a manufacturer has failed to correct the violations outlined in their Warning Letter, they may issue a recall of the products or even shut down the facility. It is important for manufacturers to stay up to date on FDA regulations and inspection processes so they can ensure compliance and avoid any costly issues.
By understanding FDA inspections, 483s and Warning Letters, manufacturers can take steps to ensure that their products are compliant with FDA regulations and protect consumers from unsafe products.
Watch our VP Troy Fugate in his first of a 5 part series as he explains how to deal with FDA inspections, 483s and Warning Letters.