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: firstname.lastname@example.org.
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/