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

Terms of Endearment

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

If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.

For this week’s guidance, Dr. D will proceed to take one parting shot at a device establishment that was awarded with a tersely-worded agency warning letter on the 28th of October of 2014. What in the heck is the purpose of scripting procedures if an establishment has no intention of ever using them? For example, this poster child for an establishment not wanting to comply with the FDA’s Quality System Regulation (QSR) decided that for whatever reason, internal audits were not important. Seriously? If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become a Chief Jailable Officer’s (CJO) best friend. However, if a device establishment has no interest in actually adhering to the policies and procedures they create, then just maybe the establishment is in the wrong industry. Maybe mining for sand in the Mohave Desert might be an option;a.k.a., filling sand bags. Regardless, this offending establishment clearly must have some sort of “heterodox” (look-it-up) opinion on compliance as their blatant failure to comply with FDA’s QSR has clearly tweaked the agency. As for the terms of endearment, the offending establishment failed to respond to the Form 483 observations, the FDA investigator left as a parting gift. Enjoy!

Warning Letter – 28 October 2014

Folks, Dr. D promises that this will be the final visitation to this establishment’s warning letter. Although all FDA warning letters offer excellent opportunities for teachable moments, some warning letters are considerably more memorable than others. This is one of those warning letters in Dr. D’s humble opinion. Not only are there serious issues associated with this establishment’s approach to compliance, or lack of, a complete failure to respond to FDA can be equated to poking a sleeping bear in the eye with a sharp stick. Be it a bear or FDA, in each case things are always going to end badly. Poke a bear in the eye with a sharp stick and the offending party is likely to end up as bear food. Fail to respond to an FDA warning letter and FDA will unleash some serious pain that can be equated to regulatory and statutory death for the offending establishment.

Warning letter excerpt

Observation eight: “Failure to establish a procedure for quality audits, and to conduct and document quality audits, as required by 21 CFR 820.22. Although your Quality Manual, QA Man, Rev. 00, CN #017, states that quality audits are required annually, your firm has no procedures in place for these audits and no evidence was available to demonstrate that any quality audits have been conducted.” Terms of Endearment: “To date, we have received no written response to the form FDA-483, Inspection Observations, issued at the close of the inspection to Mr. Thomas D. Liston, Production Manager.”

Subpart H – Acceptance Activities

Section 820.22 – Quality Audit

“Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and re-audit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and re-audits shall be documented.”

Compliance for Dummies

As many of the readers are already aware, there is no requirement to respond to Form 483 observations; however, not responding will end badly for any establishment’s failure to provide a timely and adequate response. For example, a failure to respond to Form 483 observations (within 15-days) will result in a warning letter. Failure to acknowledge the warning letter and FDA, in conjunction with the Department of Justice and the federal courts, will begin to unleash some serious regulatory and statutory pain such as product seizures, product injunctions, consent decrees, fines, and if the U. S. Attorney’s Office believes that the offending device establishment is malicious in its intent to not comply with the wishes of FDA and the federal court system; some jail time could be in the future for the CJO. The best advice Dr. D can offer the readers is just comply baby!

As for the auditing piece, the QSR has very specific requirements associated with an audit program. Dr. D also suggests reading ISO 19011 as it provides definitive requirements that should be considered for establishing an effective and robust approach to auditing. Getting back to the QSR, the salient requirements associated with an effective approach to auditing, in the eyes of FDA, are:

  • Establishing a written procedure (this is a no-brainer people);
  • Training auditors and ensuring auditors are not auditing functional areas that they oversee (the rat watching the cat syndrome);
  • Pursing corrective action when deficiencies are noted;
  • Documenting the results of audits in a written report;
  • Re-auditing problem areas to ensure corrections are actually taken place;
  • Making sure management reviews the results of all audits (placing the audit results into management review); and
  • Capturing the dates that audits performed.

The doctor would like to expand on the contents of an effective audit. For starters, the organization should consider scripting an audit plan and agenda in advance of the actual audit. A pre-audit meeting is also a helpful tool. Dr. D also strongly suggests the use of checklists to help with the audit; however, keep in mind the audit report should be the primary deliverable of the audit. During the audit, make sure a sign-in sheet is employed to capture the names and functions of all auditees, including the date of audit interviews. Do not forget to collect objective evidence of compliance or failure to comply with requirements. This information will be of immense importance, especially if corrective action is deemed necessary as a result of a minor or major non-conformance being noted.

During the audit debrief meeting, be clear and concise if non-conformances were noted. For example, personal opinions of an auditor are not relevant. The auditor should provide the specific section, clause, verse, paragraph, requirement, etc. for which an organization has failed to comply. If best practices were noted during an audit, make sure to point out the good along with the bad. Remember, there will be occasions where an audit will result in the good, the bad, and the ugly (sounds like a Clint Eastwood movie), being identified as part of the audit process.


For this week’s guidance, Dr. D will leave the readers with just one takeaway. If your establishment is awarded with a Form 483 observation, make sure a response is scripted and promptly sent to FDA. Make sure the response provided is well thought out and supported by objective evidence. If corrections are going to require some time to implement, make sure you provide the FDA with a plan. Depending on the number of Form 483 observations, providing FDA with a monthly status report might be warranted. In any event, it lets the agency know, an establishment is serious about correcting inspectional observations.

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, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International