Copies of Warning Letters are available to the public through the U.S. Food & Drug Administration’s Warning Letter Search Engine.1

For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity.  It is an open disclosure of how poorly your organization complied with specific regulatory requirements. 

The purpose for the quality management system, as required by the FDA, is to demonstrate that processes are in place that will result in devices that are safe and effective2.  The most frequent reason for a company to get a Warning Letter, is the failure to have and/or follow a required quality management system procedure. 

Thirty-eight Warning Letters were issued to medical device companies between January 2018 and August 2022.  The FDA maintains the most recent five years of Warning Letters in this database.  Following is an example of a detailed statement from one of the 2022 Warning letters, CMS# 6298443:

“The Director of Regulatory Affairs and Design Assurance… stated there was no statistical rationale for the threshold of 10 complaints [to trigger a Corrective and Preventive Action or ‘CAPA’] but explained that this threshold was selected after a review of your baseline complaint numbers. Your firm did not follow this procedure of CAPA initiation…”

A maximum FDA monetary penalty of $10,000 is permitted for “all violations adjudicated within a single proceeding”, or, if a responsible party fails to remedy its noncompliance within the notice period, $10,000 per day of continuing noncompliance.4

Additional costs may also include civil and criminal fines imposed beyond those of the FDA.  For example, one large health care products company agreed to pay a $61 million fine due to having deliberately sold faulty surgical devices and having used unsuspecting heart patients as “guinea pigs” to test new products.5

Need more information about FDA enforcement actions or help preparing a response to an FDA Warning Letter? EMMA International and I can assist you with that. Contact us by phone at 248-987-4497 or by sending an email to: info@emmainternational.com.


1 FDA Warning Letter Search Engine, from the Food & Drug Administration website current as of 08/24/2022; accessed 08/24/2022 from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

2 Quality System (QS) Regulation/Medical Device Good Manufacturing Practices: Flexibility of the QS Regulation, from the Food & Drug Administration website, accessed 08/24/2022 from: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices | FDA

3 Warning Letter CMS# 629844, posted 08/09/2022, to Zyno Medical LLC, from the U.S. Food & Drug Administration website, accessed 08/24/2022 from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zyno-medical-llc-629844-07122022

4Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff, August 2020, from the U.S. Food & Drug Administration website: accessed from: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank | FDA

5 “Firm Fined for Selling Faulty Surgical Devices”, by John Schwartz, October 16, 1993, ©1993 The Washington Post, accessed 08/17/2022 from: https://www.washingtonpost.com/archive/politics/1993/10/16/firm-fined-for-selling-faulty-surgical-devices/0d3169df-7ab7-4f40-bc45-bc04a8663273/

Diane Kulisek

Diane Kulisek

Ms. Kulisek serves as a Senior Quality Engineer and Senior Regulatory Affairs Specialist for EMMA International’s Technical Operations team. She has experience in technical writing, quality management systems, regulatory enforcement remediation, corrective and preventive action management, electronic data management systems, cybersecurity, and design controls for the medical device industry. Ms. Kulisek also has significant past experience in quality engineering and management for mass-produced consumer products, electronics, aerospace and commercial filtration industries. Ms. Kulisek holds a Master of Science in Engineering with a concentration in Civil, Industrial and Applied Mechanical Engineering Management from California State University, Northridge (CSUN) and a Bachelor of Arts in Biology with a concentration in Environmental Biology, also from CSUN. She also holds a Graduate Certificate in Program Management from West Coast University, a Lean Six Sigma Green Belt from Six Sigma Systems, Inc., and Certifications for multiple EU MDR and EU IVDR topics from Greenlight Guru. Ms. Kulisek maintained American Society for Quality Certifications for more than twenty consecutive years as a Quality Engineer (ASQ CQE) and as a Manager of Quality / Organizational Excellence (ASQ CMQ/OE).

More Resources

Pattern Recognition as a Quality Superpower

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
Record Control for a Regulated World

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
EU MDR SSCP’s: The Importance of Readability

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

Ready to learn more about working with us?

Pin It on Pinterest

Share This