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

If an Activity or Event is not “Documented” in Writing, in the Eyes of FDA, it Didn’t Happen!

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

Do not be that establishment that fails to fully establish procedures or collect relevant information needed to support claims of compliance with the QSR.

Dr. D is going to share some not so earth-shattering news with the readers. If an activity or event is not documented in writing, in the eyes of FDA (and all other regulatory bodies), it just didn’t happen.

Seriously folks, to be in a position to provide documented evidence of compliance during an agency inspection, the Chief Jailable Officer (CJO) must actually have documented evidence to share with FDA. Additionally, what is the point of scripting procedures if an establishment fails to implement the procedures?

For this week’s guidance, Dr. D is going to explore the need for documented evidence. Hopefully, the readers take this information to heart and not end up like the device establishment captured in this week’s guidance. This week’s offending establishment has clearly struck out with the agency:

  • Failure to implement procedure – Strike One;
  • Failure to complete forms required to support documented evidence of compliance – Strike Two; and
  • Failure to provide the agency with enough information to determine the adequacy of the warning letter response – Strike Three, you’re Out!

Now upon completion of an inspection, especially one that has not gone well, an investigator is not likely to provide much “palaver” (look-it-up). In fact, the doctor is quite sure that some level of pontification occurs or simply stated; “a harsh scolding” is unleashed on the CJO of the offending establishment. Enjoy!

Warning letter – 26 September 2014

Folks, this week’s warning letter recipient received a coveted FDA Warning Letter Award, because of their failure to implement key procedures and collect documented evidence of compliance. In fact, a total of eight observations were denoted in the warning letter. Now granted eight observations is far from the agency record of well over 20 observations, it is still a number that should raise the level of concern of this organization’s management team. After all, this establishment has clearly got the attention of our friends at FDA.

Warning letter excerpt

Observation Seven – Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been adequately established, as required by 21 CFR 820.200(a). Specifically, your Servicing SOP #N-001, Rev A, covers both annual recalibration and correction of equipment malfunctions. The SOP lacks specific procedures or instructions, or reference to such procedures, for performing the annual calibration activities. In addition, Section 4.3.3 requires servicing to be recorded on Form N-001-1, Service. However, you routinely perform annual calibration of the devices and the form has not been filled out as required. For example, the calibration servicing of audiometer model 650A, serial B9880, on 03/18/2014 and model 1000+, serial #23710 on 07/03/14 were not recorded on the required form.

The adequacy of your firm’s response cannot be determined at this time. Your response states these corrections are in progress. We will assess your corrective actions during the next inspection of your firm.”

21 CFR, Part 820.200 – Servicing

“(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100. (

c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of 820.198.

(d) Service reports shall be documented and shall include:

  1. The name of the device serviced;
  2. Any device identification(s) and control number(s) used;
  3. The date of service;
  4. The individual(s) servicing the device;
  5. The service performed; and
  6. The test and inspection data.

Compliance for Dummies

Dr. D would like to start with the comment, it is a pretty difficult task to comply with §820.200(b); if the information required by §820.200(d); is not being collected. Seriously, folks, what can one possibly expect to analyze if no data is being captured? In fact, how can an organization ascertain if a service call may actually be a complaint that must be reported as an MDR (in accordance with Part 803) if information relating to service calls is not being collected and documented in a service report?

No surprise here folks, if the Quality System Regulation (QSR) requires that a procedure be established, the time to start writing is now. Remember establish in FDA speak means to define, document (in writing or electronically), and implement. This is a pretty clear definition of what FDA is expecting. If the QSR states that specific pieces of information are required, guess what? You better have a way of collecting the information. Can you say form? Seriously, no CJO wants to sit across from an investigator, during an agency inspection, and not have documented evidence of compliance.

When it comes to service reports, once again the QSR is very specific as to what FDA is requiring from device establishments. As a minimum, the QSR requires:

  • The name of the device serviced, i.e., the approved marketed name of the device (check the 510(k) or PMA if you are not sure);
  • Any device identification(s) and control number(s) used, i.e., part number and serial number, as appropriate;
  • The date of service, not the day before the service was performed; not the day after the service was performed; the actual day of the service was performed;
  • The individual(s) servicing the device, e.g., the actual names of the individual(s) performing the service, not nicknames, not initials, but the actual names;
  • The service performed, provide as much granularity as necessary; and
  • The test and inspection data, the actual data recorded and whether the results were deemed acceptable, e.g. Pass or Failure.


Folks, for this week’s takeaway, the doctor is just going to briefly pontificate. Please do not be that establishment that fails to fully establish procedures or collect relevant information needed to support claims of compliance with the QSR. Your CJO will appreciate the effort as will FDA. Trust Dr. D when I say, FDA takes no joy in writing a boatload of observations for an establishment that fails to comply with the QSR. Why? Because it is also significant work for the agency to draft the Form 483, subsequent warning letter, and then micro-manage the offending establishment until they come back into compliance with the QSR. It really starts to get expensive, if the need to elevate regulatory action occurs, e.g., consent decree.

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. (2013, April) 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’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416625.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International