Project reference

Organization of an FDA audit

A client wants to prepare for a pending FDA audit. EXCO is asked to inspect the QM system in regard to its conformity with the requirements of FDA 21 CFR Part 820 and to highlight possible gaps in the documentation and implementation of the QM system, especially those associated with products that are approved in the USA.


EXCO creates a detailed audit plan based on FDA 21 CFR Part 820 requirements and completes a mock audit. In this context, the process descriptions and product documentation were checked as well as company departments such as production, packaging, storage and incoming goods.

Client benefits
  • The client receives a detailed final report which highlights the potential gaps in their QM system.
  • Due to native speakers in the audit team it was possible to study the documents quickly and efficiently.
  • The client is now optimally prepared for the pending FDA audit.


Medical equipment manufacturer, Hungary

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