Spike in FDA Warning Letters in 2012 Raises New Focus

For the first time since 2002, Device History Records and Nonconforming Product were among the top five FDA Warning Letter citations in 2012, according to the European Compliance Academy (ECA), which bases its analysis on inspectionthe fiscal calendar. We also saw an overall increase of sixteen-percent in Warning Letters from 156 issued in 2011 to 181 issued in 2012. In 2010, the Center for Devices and Radiological Health (CDRH) issued 182 Warning Letters, citing Corrective and Preventive Actions and Complaint Records most, followed by Design Control, Process Validation, Receiving, in-process, and finished device acceptance, and Management Responsibility respectively.

warningThe purpose of a Warning Letter, according to FDA is to ensure that the seriousness and scope of the violations are understood by top management, and that the appropriate resources are allocated to fully correct the violations and prevent their recurrence.

Historically, 21 CFR 820.100 Corrective and Preventive Action is cited most in Warning Letters issued by CDRH. According to ECA, only once in the last 10 years has another section of the Quality System Regulation been cited in Warning Letters issued by CDRH more than CAPA. Fifty-seven-percent of the Warning Letters issued in 2007 contained citations for Design Control deficiencies. Nearly 30% of the Design Control violations were in the areas of verification and validation, while nearly 12% cited violations in Design Changes.

increaseThe number of warning letters issued by CDRH has increased significantly since mid-2009, when FDA announced that it would no longer require the Agency’s Office of Chief Counsel to review letters for legal sufficiency except in cases involving “significant legal issues.” The goal of the new policy was to  increase enforcement and to limit enforcement delays, and the results were staggering. Industry was, for a lack of a better word, alarmed by an increase in Warning Letters issued by CDRH of 117% from 84 Warning Letters in 2009 to 182 Warning Letters in 2010.

In the ten year period between 2002 through 2012, CDRH issued an average of 83 Warning Letters through 2009. Since 2010, CDRH has issued an average of 173 Warning Letters per year to medical device manufacturers. The Agency’s goal is to prioritize follow-up on all Warning Letters and other enforcement actions, working quickly to assess corrective action taken by the manufacturer. As part of its commitment, FDA introduced its formal Warning Letter close-out process. If the Agency determines that a manufacturer fully corrected the violations, it will issue an official close-out notice, and post it to the FDA website.

Medical-manufacturingAmong the common violations cited in Warning Letters, a new trend developed in nonconforming product and Device History Record violations in 2012. Medical device manufacturers were cited for failure to establish and maintain adequate procedures, and identify and adequately investigate the root cause of nonconforming product. Among the citations, manufacturers failed to establish and maintain adequate procedures for rework, retest and reevaluation of nonconforming product, and maintain adequate Device History Records.

Ten Warning Letters issued by CDRH have been posted to the FDA Warning Letter database online since January 1, 2013. Half of the Warning Letters issued so far this year cite Medical Device Reporting violations, six cite Quality System Regulation violations, one cites misleading promotion and advertising, and one cites a lack of clearance or approval to market the device.

Quality System Regulation violations in published Warning Letters issued by CDRH this year are summarized in the table below. So far this year, 13 Design Control violations, 13 Records violations,  10 Production and Acceptance violations, eight CAPA and Internal Audit violations, and three Nonconforming Product violations are cited in the top five areas of the quality management system.

Section Title Violations
820.30 Design Control 13
820.198 Complaint Record* 6
820.80 Receiving, In-Process, and Finished Device Acceptance 5
820.70 Production and Process Controls 5
820.181 Device Master Record 4
820.100 CAPA 4
820.22 Internal Audit 4
820.184 Device History Record 3
820.90 Nonconforming Product 3
820.250 Statistical Techniques 2
820.40 Document Control 2
820.50 Purchasing Controls 1
820.72 Inspection, Measuring, and Test Equipment 1
820.20 Management Responsibility 1
820.75 Process Validation 1
820.120 Device Labeling 1
*Five Warning Letters also cite Part 803 violations

A greater focus this year should be directed toward Design Control, Records, Production and Process Controls, Acceptance Activities (including Nonconforming Product) and Internal Audit.

About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.

  • I think I’d love this even more if I fully understood all the moving parts. F’rinstance, what’s Part 803? How does that intersect w/Part 820 violations, particularly when the two are issued on the same issue? From my “let patients help” row, educating the average Joe/Jane on this could add some weight to driving change in the device and pharma industry for the good of all – the companies, the clinicians, the patients, the world at large. Educate us!

    • Thanks for commenting, Casey!

      Part 803 is important not only to manufacturers, but to the patient, as well. I should go into more detail about this topic, but it’s a blog post all its own.

      In a nutshell, Title 21 of the Code of Federal Regulations entitled, Food and Drugs, under sub-chapter H, Part 803 is the Medical Device Reporting regulation.

      This Part pertains to how manufacturers, distributors, importers, and user facilities report problems relating to safety and efficacy of a device to the FDA.

      The Agency implemented, MedWatch, the FDA Safety Information and Adverse Event Reporting System for clinically important safety information and reporting serious problems with human medical products.

      For manufacturers, distributors, importers, and user facilities, a Medical Device Report is mandatory when a device directly causes a death or serious injury, or if a malfunction of the device caused (or could potentially cause) a death or serious injury.

      It’s important to note that a serious injury is defined as an injury or illness that: (1) is life threatening, (2) results in permanent impairment of a body function or permanent damage to body structure, or (3) necessitates medical or surgical intervention to preclude permanent damage to a body structure.

      These reports are entered into a database at FDA. The manufacturer is required to conduct an investigation to determine the root cause(s) and any changes needed to prevent recurrence.

      It’s also important to note that a manufacturer’s submission of the Medical Device Report, and subsequent investigation report are not admissions of guilt.

      MedWatch extends to the consumer, as well. Anyone who has experienced a serious reaction to a medical product, or knows someone who has, is encouraged to take the reporting form to his/her doctor. The health care provider can provide clinical information based on the medical record that can help FDA evaluate the report.

      However, the health care provider is NOT required to report to the FDA, if a patient doesn’t want the doctor involved. Consumers may complete the Online Reporting Form themselves.

      FDA sends an acknowledgement letter when they receive the report. Reports are reviewed by FDA staff.

      Note: FDA will only contact consumers if they need more information. They do not provide results of their review.

      The MedWatch reporting system can be accessed here:


      Thanks again!

      • Thank YOU for opening up a whole new epatient head chakra for me!

        • LOL! Anytime! I’m glad I provided some enlightenment. I made a note to write a blog post about reporting, also. It’s a fairly large topic to explore. Especially for manufacturers. It gets even more complex when they distribute product to other countries. There are different requirements everywhere. It’s a maze.

          • Chaos behind a wall of fog? Just like the rest of healthcare …

          • You got that right, Casey! And, the bigger the organization grows, the more complex it gets.