The FDA has just completed an inspection of your firm, and one or more FDA Form 483 inspectional observations were noted by the inspection team. How and when your firm reacts to these observations is a significant decision.
In your response, the FDA wants to see a plan of action. Automated Systems helps guide our clients through this critical phase and create that plan. Automated Systems can then provide the expert resources to make that plan a reality by remediating any quality system deficiencies found during the FDA inspection. ASI provides the following services to our clientele:
- FDA Response & Remediation
- Rapid Response to Inspections and 483s
- Remediation Support for Consent Decrees, Warning Letters, and 483s
- On-Site Quality System Remediation
- Project Management
Since it’s their job, FDA inspectors will often find deficiencies, despite your best efforts. These deficiencies will be listed on a form entitled “Inspectional Observations”, or Form 483. The 483 formally notifies the organization’s top management of objectionable conditions or practices relating to violations of the Federal Food, Drug, and Cosmetic (FD&C) Act that were observed during the inspection.
Once a 483 is issued, there is a 15-day period during which the FDA will await your written response to the 483. It is critically important that a written response to the 483 is delivered to the FDA within those 15 days.
A company’s 483 response is a critical part in determining whether or not a Warning Letter will be issued.
Of course, going back in time, it would have been better to have never received those observations in the first place, which is why Automated Systems provides a full range of inspection readiness services.
- FDA Inspection Readiness & Support
- Inspection Planning
- Personnel Training & Auditor Interview Preparation
- Subject Matter Expertise
- Post-Inspection Analysis