One Monday morning in November, an FDA Inspector visited Gateway to perform an inspection. Although we are FDA registered, it came as a complete surprise. It is times like these when you realize how important it is to have a quality management system that is designed to be ‘audit-ready’ at all times. Implementing checks and double checks of all systems (e.g. training, calibration, CAPA, document control, etc.) is crucial for ensuring everything is kept up-to-date per internal procedures and regulatory requirements.
We survived the FDA inspection with no 483s. That was exceptionally good news. Because as you know, FDA inspections are public record, so a poor inspection that results in numerous 483s can be detrimental to a laboratory’s pharmaceutical business and reputation.
Committing to quality can be an expensive venture; however, not committing to quality can result in much higher expenses due to poor audit performances (both FDA and customers) and eventual lost business. Also remember that it is much more expensive to retroactively and reactively ‘fix’ a quality system. So given the choice, make the investment and commitment to quality and continual improvement; the business will follow.