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What are the top three issues seen in FDA 483 observations involving quality system requirements at medical device manufacturers?

Per the FDA and other regulatory agencies, medical device manufacturers are required to ensure their quality systems adhere to GMPs.

But are there specific aspects of quality system requirements that should receive greater focus? What are FDA investigators concerned about the most when it comes to medical device GMP operations?

With Redica Systems’ advanced data analytics, we can better understand the top three issues regarding quality system requirements.

A report for the past five years’ (2017-2021) worth of 483 observations issued to global medical device manufacturers shows the following top three observations involving quality system requirements.

  • Quality Audits
  • Training
  • Management Review
Top Medical Device QSR issues
Redica Systems Enforcement Analytics | Quality Systems 483 Observations

If your quality and compliance team is responsible for inspection preparation for medical device GMP, these are three areas you may want to focus on ahead of your next inspection.

Additional areas of concern identified by FDA investigators at medical device facilities include process capability, CAPA effectiveness checks, and inadequate cleaning validation programs.

Inspection Preparation for Medical Device GMP

Our inspection intelligence gives you unique insight into the latest agency inspection trends across inspection types. With Redica Systems, you can generate critical medical device insights with our actionable data intelligence. We will help you search, analyze, and derive valuable insight from thousands of data points covering medical devices and combination products, contract manufacturers, products, inspections, and enforcement.

Contact us to see how we can provide you with the latest insights on medical device GMP enforcement trends.

Additional Medical Device Resources

Process Capability in Focus in FDA Device Inspections

ORA Targets CAPA Effectiveness Check Deficiencies

Many Device Cleaning Validation Programs Need Work, FDA Investigator Says

Best Practices for Responding to a Medical Device FDA 483


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