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Is your organization ready for an FDA inspection on Quality Systems?

The Food and Drug Administration (FDA) inspections against the Quality System Regulation (21 CFR Part 820) are focused on evaluation of procedures and documentation. Four major subsystems of the Quality System have been specified; Management Control; Corrective and Preventive Actions (CAPA); Design Controls; and Production and Process Controls (P&PC). This means that the CAPA subsystem will most likely always be part of a Quality System Inspection Technique (QSIT) conducted by the FDA.[1]

The fact that CAPA is consistently at the top of the FDAs frequency of 483 findings supports that it is a guiding principle for inspections to evaluate the CAPA process. Findings related to the CAPA regulation (820.100) make up about 13% of all FDA 483 findings at Medical Device companies over the past three years. The two most frequent CAPA related findings establish that some companies in Medical Device industry do not have an adequate CAPA procedures or documentation. [2]

  • “Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***”
  • “Corrective and preventive action activities and/or results have not been [adequately] documented. Specifically, *** “

Does your organization have an adequate quality system supporting all procedures regulated by the FDA or ISO13485:2016, as well as other country-specific regulations?

HERAX has experience from projects in this area and can support your organization with:

  • Assessing and implementing Quality Management Systems (QMS) to support the CAPA procedure and documentation requirements.
  • Harmonizing and documenting other QMS related processes such as Audit Management, Complaints Management, Medical Device Reporting, Nonconforming Products.

For more information, please visit www.herax.com or contact Allan Bech Thomsen directly on +45 3049 2100 or This email address is being protected from spambots. You need JavaScript enabled to view it..

 

[1]:  (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/performing-subsystem-inspections, n.d.)

[2]: (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations, n.d.)