“What happens if I don’t respond to my FDA-483 within 15 days?”
If you find yourself asking this question, you will need a roadmap. There are steps to take to ensure you don’t miss the deadline, and details that you might need help with. The plan for responding to an FDA form 483 may follow these steps:
- Organize your team and establish a timeline to respond
- Identify where the issues originate
- Issue Corrective and Preventative Actions (CAPAs)
- Identify your team’s timeline to address the 483’s as quickly as possible
- Develop your response letter
- Prepare your organization for re-inspection
In each step listed above, there are details and nuances that you won’t want to miss, and that’s where Lachman Consultant Services, Inc. (Lachman Consultants) can fill the gap.
With Lachman OnCall™ GMP Teleconsulting, you can get questions like these answered, in hours, not days, at affordable pricing. Lachman Consultants’ Subject Matter Experts (SMEs) have extensive knowledge of complex scientific, technology, and compliance issues. With longtime experience working in FDA and industry, they are skilled at navigating your toughest questions with valuable and timely responses. Lachman Consultants’ Science and Technology SMEs work efficiently and effectively to address your issues with a thorough and balanced approach and provide answers to your most pressing scientific and technical questions. Lachman Consultants’ Compliance SMEs are a team of highly qualified experts who consistently deliver thoughtful and comprehensive advice for compliance-related matters.
SMEs are available Monday through Friday, 9:00 am – 5:00 pm ET, generally responding within two (2) hours on weekdays; and within twenty-four (24) hours after normal business hours, or on weekends and holidays. When you can’t wait, don’t. Contact Lachman OnCall™ through the Lachman OnCall™ web page. All the advice you need, when you need it most.
