FDA Form 483 Inspectional Observations and Warning Letters Support:
A Form 483, also known as “Inspectional Observations,” may be issued at the conclusion of your quality conformance inspection with a nonconformance report that cites certain conditions that may violate the Federal Food, Drug, and Cosmetic (FD&C) Act. A warning letter is considered an escalation of the Form 483. Whether you’re dealing with a Form 483 or the more serious FDA warning letter, we’ll help you respond to the notice within the required timeframe and address the violations in question.
With our QMS compliance and remediation knowledge, we’ll help you figure out how to answer a nonconformance report by specifically helping you:
- Analyze the findings of the FDA Form 483 and/or warning letter to understand what the nonconformance is
- Develop a nonconformance management procedure to address the deficiencies
- Create a timeline for implementation
- Lead or assist in the implementation of the plan to address the deficiencies
- Act as an interim management representative
- Field questions from you or the FDA during corrective action activities
Don’t learn the consequences of nonconformance the hard way. For more information about our QMS compliance and remediation services or how we can help you develop a nonconformance standard operating procedure to ensure QMS compliance with regulatory bodies, contact us here.
Sterling’s independence gives you the flexibility to work with a medical device quality system that is optimized for your needs. Whether it’s creating a medical device quality system from scratch with our team, remediation and reconstruction of an existing one, or relying on one of our own formulated quality systems, quality is Sterling’s priority.