BioTeknica

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Did You Know?

The FDA has increased its focus on enforcement by hiring 25% more investigators and has increased the number of Warning Letters issued – more in the first six months of 2011 than for all of 2010!

483 Observations Will Cost You.

In our experience, it takes approximately three times the man hours to respond to an observation than to prepare. Remediation, revenue loss and/or penalties can be 10 -1000 times the investment to prepare.

The Devil is in the Details: What You Could Be Missing

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 Key Questions to Assess Inspection Readiness

  1. Have you assessed and addressed all potential internal and external compliance risks?
  2. Are you aware of all the current inspection trends as they specifically relate to your products?
  3. Have you reviewed your processes with a critical eye, viewing them from the FDA’s perspective?
  4. Do you have a trained inspection readiness team in place and is your management team prepared?
  5. 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?
  6. Do you have an established process to fulfill the investigator’s request?
  7. Has an independent third-party objectively assessed your vulnerabilities and provided practical, cost-effective business solutions to your satisfaction?
  8. Are you ready to provide your data in an electronic format?
  9. Do you have strategies in place to handle potential compliance vulnerabilities during an audit?
  10. If you were notified of an inspection today, would you be able to pass with flying colors?

If you answered “no” to any of these questions or are not 100% confident, call to ask about our S3 Inspection Readiness Services.

Increase your odds for a favorable outcome
Contact BioTeknica at inspectionreadiness@bioteknica.com

Increase your odds for a favorable outcome

S3 Inspection Readiness Services is a simple, systematic, and sustainable approach to better prepare for inspections. We provide established and emerging medical device, diagnostics and pharmaceutical manufacturers with: