S3 FDA Inspection Readiness Services
Are You Ready?
Have you done everything possible to prepare for your next FDA Inspection?
Are you gambling with your next inspection?
Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertain your site’s true readiness. Our regulatory professionals quickly identify your vulnerabilities and prevent or mitigate them from becoming significant compliance issues. Our systematic, proven, risk-based approach and experiential learning go beyond the traditional “mock audit” to prepare SMEs and staff to competently respond to all investigator queries. Avoid inspection surprises. Prepare early, often, and thoroughly.
Inspection Readiness services:
Simulated Inspections
Risk-based preparation
Inspection oversight and management
Experiential learning for SMEs
483/Warning Letter Responses
Training & Education
Did You Know?
The FDA has increased its focus on enforcement by hiring more investigators and has increased the number of Warning Letters issued.
In our experience:
It takes approximately three times the man-hours to respond to observation than to prepare
Remediation, revenue loss, and/or penalties can be 10 -1000 times the investment to prepare
You’re experienced and may have a great in-house team. So, you’re thinking, why not prepare for an inspection on your own? Just as GMP requires an independent review of your quality records, you also need an independent and unbiased review of your site’s readiness.
10 Questions to Assess Inspection Readiness
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- Have you assessed and addressed all potential internal and external compliance risks?
- Are you aware of all the current inspection trends as they specifically relate to your products?
- Have you reviewed your processes with a critical eye, viewing them from the FDA’s perspective?
- Do you have a trained inspection readiness team in place and is your management team prepared?
- Are you confident that all of your employees can competently answer the FDA’s questions and provide clear explanations of your processes and quality records?
- Do you have an established process to fulfill the investigator’s request?
- Has an independent third-party objectively assessed your vulnerabilities and provided practical, cost-effective business solutions to your satisfaction?
- Are you ready to provide your data in an electronic format?
- Do you have strategies in place to handle potential compliance vulnerabilities during an audit?
- If you were notified of an inspection today, would you be able to pass with flying colors?