Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Perils Plague Warning Letter Recipients

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

No reviews of pre-market applications and no certificates to foreign governments signed—ouch!

Sometimes bad things just happen when a device establishment receives far too many Form 483 observations during an agency visit for a cup of coffee and an inspection. In fact, during a month-long visit to a device establishment located in the Volunteer State of Tennessee, an investigator from the agency managed to script eight Form 483 observations for a plethora of violations. Dr. D is pretty sure the protracted visit was not due to the investigator wanting to pay homage to the Jack Daniels’ distillery located in that magical place named Lynchburg, TN. FYI, the doctor and his evil twin (JT) spent many a night consuming the golden nectar known as sour mash. Now granted, on rare occasions, a device establishment earning a large number of Form 483 observations is able to preclude the issuance of the dreaded agency warning letter by scripting a robust response to each of the observations. However, that does not appear to be the case for an offending establishment earning the not-so-prestigious warning letter award in May of this year. There is no doubt in the Dr. D’s mind that the CJO(s) were not in the mood for jubilation (look-it-up) after this visit from our friends at the agency. Enjoy!

Warning Letter –May 12, 2016

Now instead of boring the readers with some of the eight Form 483 observations awarded to this offending establishment, the doctor will expand on the perils of what happens to warning letter recipients. For those of you not familiar with the FDA’s powers of persuasion, they can definitely ruin the day off the offending establishment’s management team (Chief Jailable Officers) quickly (i.e., the president, the chief financial officer, the chief operating officer, etc.). You see, the agency has one really strong belief in quality compliance and the importance of designing, manufacturing and introducing into commerce medical devices that are safe and effective in their intended use. As you will quickly see in this week’s warning letter excerpt, the agency has decided to open up a can of regulatory pain and unleash two powerful tools and a threat of additional regulatory action. Ouch!

Warning Letter Excerpt

“Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of warning letters about devices so that they may take this information into account when considering the award of contracts.

Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this warning letter.”

Compliance for Dummies

Not wanting to state the obvious but obliged to do so, being on the receiving end of an agency warning letter is a bad thing. Do you think? The FDA quickly learned that the best way to garner the attention of offending establishments is to shut down the new product pipeline by not reviewing pre-market applications and not signing the Certificates to Foreign Government (CFG) until the violations are corrected. If you were able to surmise that these actions adversely impact an establishment’s fiscal health (a.k.a., the proverbial bottom line), you would be correct. For those of you that have never experienced the joy of a warning letter, it is no fun having new product development placed on hold and shipments outside of the United States coming to a screeching halt when CFGs expire or no new CFGs are forthcoming. Additionally, competitors are all too happy to fill the medical device orders that an offending establishment is no longer able to fill due to regulatory restrictions.

But wait, there is more! If the offending establishment fails to respond to the warning letter within the allotted 15 business days, provides the agency with a really crappy response, or fails to provide objective evidence of compliance or a serious attempt at remediating the warning letter, then FDA just might back up that old turnip truck and collect some violative inventory (a.k.a., adulterated product). Can you say detention? Dr. D is not talking about the after school kind the doctor was extremely fond of as a youngster. Seriously, the FDA, with the help of the United States Attorney’s Office, the federal courts, and a few U.S. Marshalls, can provide a powerful incentive for the CJO’s to work quickly, diligently and hopefully intelligently in bringing their establishments back into the good graces of the FDA. No self-respecting CJO’s like to arrive at work with chains and padlocks on the doors.


For this week’s guidance, the doctor will provide the readers with two takeaways. One: If an establishment inspection results in your organization being on the receiving end of Form 483 Observations, do not panic. Provide the FDA with clear and concise responses that identify:

  • Containment activities
  • Root causes (please do not blame an observation on training)
  • Immediate actions pursued
  • Actions taken to preclude a recurrence of the violations
  • What constitutes verification of effectiveness

Two: If a warning letter is the byproduct of the inspection, shred everything and move to the Cayman Islands (just kidding). Work quickly, diligently and hopefully intelligently in bringing your establishment back into the good graces of the FDA. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.


  1. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
  4. FDA. (May 12, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Somnowell, Inc.  Accessed May 24, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501557.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International