FDA is authorized to inspect regulated facilities and point out problems. How a firm responds to the inspection and how it plans to correct the problems has a significant impact on how the FDA treats the firm after an inspection. Firms usually do not know the key points that sway the FDA’s evaluation and classification of an inspection. What you say and how you say it has a major impact. This information is fundamental to any FDA regulated firm.

FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection, the FDA investigator makes a “list of observations” that gives examples of violations. The list is known as the “483.” Some observations are very serious and can easily lead to receiving a Warning Letter, which threatens legal action. Your response to a 483 plays a critical role in how the agency will evaluate the inspection.  A poorly written response or not responding at all will certainly lead to a Warning Letter and follow-up action by the FDA.

Areas Covered:-

• How to respond to a 483
• How to interpret the 483
• What to say and not to say when FDA issues the 483
• Submitting your written response to the 483 observations
• Inspection procedure for identifying non-compliant practices
• Discussions during the inspection with the FDA
• Planning for the discussion with the FDA at the conclusion of the inspection
• The firm’s 483 response team
• Organization of your written response
• Use of FDA’s Compliance Program Guidance Manual (CPGM)

Who Will Benefit?

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.

• Regulatory Affairs Director
• Manufacturing Director/Manager
• Quality Assurance Manager
• Production Managers
• Operations Finance Managers
• Complaint Department Manager
• Product Development and Support Manager