Understanding and Avoiding FDA Warning Letters

By Sharon Mulligan, Program Director

What is a warning letter?

The FDA regularly conducts inspections of facilities involved in medical device development and manufacturing to ensure compliance to their regulations. When violations are found, they can result in the issuance of public warning letters (which are posted on the FDA website) or the seizure of product inventory. The FDA can also obtain a court injunction prohibiting further marketing of the product or assessing civil money penalties. What topics monitored by the FDA specifically concern medical device companies?
How, why and when is a warning letter issued?

• Registration: Companies must register annually and list the devices they make.
• Bioresearch: The FDA monitors any and all bioresearch that goes into devices – e.g. studies, surveys, and clinical trials.
• Quality Systems: Manufacturers must establish and adhere to FDA-approved quality systems to ensure consistency and fulfillment of stated user needs.
• Recalls: If completed devices are found to be unsafe or failing, the establishment will issue recalls but must notify the FDA as well.

Audits are conducted on company property by the FDA, and if the documentation cannot be tracked down to provide sufficient evidence of compliance during the audit period (usually spanning several days), a warning letter may be issued. The warning letter will state the regulation and the specific findings of the investigator which demonstrates the violation.

As an example the recent focus at the FDA in making sure that device manufacturers incorporate Human Factors into the development process might be audited during an inspection by examining company’s procedures and design history files for evidence of design validation. Design validation is a requirement to demonstrate that the final production device conforms to defined user needs and intended uses. A company’s inability to provide validation reports showing user needs were established and are met with the final product might result in a warning letter.

And realize…

Outsourcing your business to good partners is imperative. The FDA releases its warning letters to the general public, therefore the issuance of a warning letter to any establishment ultimately harms reputations.

What measures should be taken to ensure that this won’t happen?

Ximedica takes rigorous measures to ensure our Quality Systems are thorough and comply with the regulations. We have built our Quality Management System (QMS) from the ground up to marry the rigors of the FDA with lean development best practices. The system has also been designed to be easily updated with consideration for maximum cognition. Some of the most significant safety nets we’ve developed as part of the QMS related to the design validation example include:
On a day-to-day basis, Ximedica’s employees—engineers, designers, researchers and developers, regulatory and of course quality folks—make sure to adhere to the Standard Operating Procedures created by our Quality Systems group. Everyone receives regular training, and we are audited regularly by our Notified Body, as well as by clients. Projects utilize our QMS through all product development phases.

• Ximedica’s SOP-1001, Document and Data Control, and SOP-1019, Quality Systems Record Retention, to make sure that documentation is controlled for accuracy and available as evidence.
• Ensuring the validation of every user need by:
  • Documenting user needs in System Design Specification (F-1050) during Phases 0-1
  • Tying the validation results to each user need in a Traceability Matrix (F-1215)
  • Following our design validation process: SOP-1049, User Centered Design & Development and Design Validation

Learn more about Ximedica’s comprehensive Quality System.