Clarkston Quality and Compliance Expert Shares Guest Column on FDA Form 483 Inspection
September 1, 2023 | Clarkston Consulting’s Susan Shockey, an expert on quality systems, quality process improvement, and inspection preparation and remediation, was recently featured as a guest columnist with Outsourced Pharma for perspectives and best practices surrounding FDA Form 483 inspections. Read a few excerpts from the piece below or the full article here.
5 Best Practices For Responding To FDA Form 483 Inspection Observations
A review of published warning letters confirms that a significant percentage could have been avoided by a proper response to the Form 483. Our goal is to help you take appropriate actions to optimize the outcome after receipt of FDA observations. The following steps will guide your actions toward an optimal response to FDA Form 483 inspection observations.
- Understand the observation
- Investigate the findings
- Develop a corrective and preventive action plan
- Respond to the FDA
- Follow up and prepare for future inspections
Following these steps will ensure that the findings are properly addressed, and this can be used as an opportunity to not only correct the identified issues but also uncover related issues and correct them to improve your overall quality system.