FDA Audit

How To Prepare For An FDA Audit

An FDA audit is inevitable for any organization that manufactures or processes medical equipment, devices or drugs. Once the inspector enters the building, it might leave your leadership and team members feeling one of two ways: A calm excitement for the prepared organizations that are prepared and ready to successfully go through the audit, or dreaded panic for those who never actually got around to prepare for one even though they knew they should have. 

Here are 3 tips on how to best prepare for an FDA Audit:

1. Have Clear and Concise FDA Audit Procedures

Clear communication between leadership and employees is key for a smooth audit. To do so, organizations should use simple language in audit preparation documents and not over complicate what should be a clear list of dos, don’ts and contact informations. 

Instructions should be boiled down to essentials such as:

“When asked a question by the investigator, answer only the question asked of you.”

“If you don’t know the answer to a question, don’t guess. Inform the investigator that you don’t know, but will find out for them.”

“If an issue arises, don’t attempt to quickly resolve it in front of the investigator.”

2. Compile Key Documents and Records in an easily accessible binder or system.

Depending on the size of the facility, an FDA audit might take days or weeks or, in some extreme cases, even months. The best way to ensure that audits go smoothly and efficiently is to prepare ahead of time by compiling all necessary documents and records as well as labeling all processes for easy access and retrieval.

Here is a list of items organizations should be ready to provide:

  • Important procedures related to document/change controls, complaint handling, CAPA, etc.
  • All product complaints and CAPAs since the organization’s last audit
  • Records of all corrections and recalls in accordance to Part 806.10
  • Quality system overview including a Quality Manual if applicable
  • Organizational charts & tables
  • Job/role descriptions and training protocol/records
  • Device listings
  • Responsibility matrices

3. Practice Makes Perfect: Run Mock FDA Audit Scenarios To Ensure Preparedness

The best way to ensure that an organization is prepared for an audit is to regularly run mock FDA audit scenarios to ensure that leadership and every employee know their roles and responsibilities for the real event. While these mock audits are usually conducted internally, organizations can benefit from occasionally bringing in an unbiased third party company to professionally replicate an FDA audit.   Contact Precision Life Sciences to learn how we can assist with your FDA Audit.