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

FDA a Pain in the Butt for Hemorrhoid Management System Establishment

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

Failure to provide records during an inspection will undoubtedly lead to a warning letter.

Dr. D would like to begin this week’s guidance by thanking all of the readers that have served in the armed forces, as today is Veteran’s Day in the United States. As many of you already know, the doctor was a United States Marine. In fact, yesterday (November 10) was the Marine Corps 240th Birthday. Semper Fi!

This week’s guidance will focus on a hemorrhoid management system establishment that was on the receiving end of some of the FDA’s tough love, a warning letter; henceforth, the pain in the butt reference in the title. Seriously, you just cannot make this stuff up.  When the agency appears in the lobby of a device establishment for a cup of coffee and an inspection, the investigators are not there for the delectation (look-it-up) of the Chief Jailable Officer (CJO). They are there to conduct an inspection and collect evidence should non-compliances with the quality system regulation (QSR) be noted. People, simply stated, they are collecting evidence that can be used in the federal courts, should that ever become a necessary option. Enjoy.

Warning Letter – August 27, 2015

This week’s warning letter actually mentions the typical trials and tribulations associated with device establishments that are struggling with compliance issues. However, having record control issues, including the failure to be able to provide records to the investigator during an inspection is always going to end badly. Considering most investigators enter a device establishment’s quality management system (QMS) through the CAPA system, not actually having CAPA records is really going to end badly for the CJO and the establishment he or she represents. Can you say warning letter?

Warning Letter Excerpt

Observation Eight: “Failure to have required records, as required by 21 CFR § 820.180. For example, your firm was unable to locate records, such as CAPA files for CAPA #0508.085 through CAPA #0508.093; however, sequentially, a record of CAPA #0508.084 (CAPA record prior to the missing records) and a record of CAPA #0508.094 (CAPA record subsequent to the missing record) are maintained on file by your firm. The request for the records was made by the FDA investigator during the inspection. The CAPA records were never received.”

“We received a written response from you, dated May 5, 2015, concerning the investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, which was issued to your firm. Your response did not provide adequate supporting evidence that the referenced corrections and planned courses of action have been implemented.”

Subpart M – Records

21 CFR, Part 820.180 – General Requirements

“All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

(a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.

(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

(c) Exceptions. This section does not apply to the reports required by §820.20(c) Management review, §820.22 Quality audits, and supplier audit reports used to meet the requirements of §820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.”

Compliance for Dummies

Folks, Dr. D is going to share a tiny-little secret with you: “Records equate to documented evidence of compliance.” The FDA is very clear, throughout the entire QSR, where records are expected to be collected and retained. In fact, the agency even states which records are not required to be shared with investigators (only evidence that these activities are occurring):

  • Management reviews
  • Quality audits
  • Supplier audit reports

However, not having records of CAPA, similar to the establishment mentioned in this week’s guidance, means bad things are going to happen.

Additionally, the doctor recommends training all employees in the art of Good Documentation Practices (GDP). You see, the agency actually likes to be able to read and review records during an inspection. Poor GDP can make that task difficult. In fact, if the GDP is really bad, a Form 483 observation becomes a real possibility.

Furthermore, records have to be reasonably accessible during an inspection. If records are being stored off-site, ensure that they can be quickly retrieved during an inspection. If your establishment employs a third-party record retention facility such as Iron Mountain (no, Dr. D is not a paid spokesperson for this company), make sure retrieval requirements are clearly delineated within the supplier contract. If the doctor was an FDA investigator, I would want requested records yesterday. However, within an hour is probably going to be reasonable. Just make sure the investigator is aware that the records are stored off-site and every effort will be made to retrieve requested records as expeditiously as possible.

Moreover, make sure records are being stored in a manner that actually protects the records (especially paper) from deterioration.  Many moons ago, in a far-off land known as California, the doctor was tasked with performing an audit at a record storage facility. The rodent dropping noted near the bank boxes should have been Dr. D’s first hint that something bad had happened. Seeing partially consumed device history records (DHRs) was confirmation that some rodent was feasting off the DHRs for a very-long time. In fact, the doctor was quite sure it was a family affair. Regardless, records shall be preserved. In the eyes of FDA, these records shall be persevered for at least two years (after the last device lot has been entered into commerce). 

As for electronic records, please ensure back-ups are daily. The doctor also recommends installing a viable data management system, if at all possible. Such systems allow ample control over records and access to records.


For this week’s guidance, the doctor will leave the readers with three takeaways. One: Records are a CJO’s best friend and support documented evidence of compliance. Two: Make sure records are being appropriately maintained. Electronic records should be backed up daily and paper records should not become a Thanksgiving feast for the local rodent population. Three: Accuracy counts, so please ensure GDP is strongly enforced. Why? If a record is not legible, it is just not a viable record. 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. (2015, 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. (August 27, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Ultroid Technologies, Inc. Accessed November 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International