It never ceases to amaze Dr. D when I come across an agency warning letter that cites an observation as basic as collecting and maintaining basic records such as the Device History Record (DHR). That being said, the doctor felt it appropriate to reinforce the importance of the DHR and the need for such a record to support claims of compliance with 21 CFR, Part 820.184 and the basic fact that finished medical devices were manufactured in accordance with the Device Master Record (DMR).
Additionally, it is simply not enough to have a DHR as a record. The expectation is that the DHR be properly completed employing Good Documentation Practices (GDP). To summarize the content of this week’s guidance, the FDA expects a DHR, that supports compliance with the DMR, to be completed using GDP; (a) FDA; (b) DHR; (c) DMR; and (d) GDP. Failure of the Chief Jailable Officer (CJO) to provide the agency with documented evidence of compliance during a friendly investigation will result in a Form 483 observation. Rack up too many 483s and a warning letter will be in the future of the offending establishment. An offending establishment awarded with an agency warning letter will result in the CJO establishing an “epistolary” (look-it-up) friendship with the FDA as monthly updates/letters to FDA will become the norm. That being said, Dr. D hopes you enjoy this week’s guidance.
FDA Warning Letter Dated – 28 April 2014
The warning letter the doctor selected for this week’s guidance is fairly typical with multiple violations of the QSR cited from a number of different areas. However, when compliance issues are noted with the DHRs and the DHR accuracy, the level of concern of the FDA investigator is quickly elevated. You see, the DHR is essentially the manufacturing/production traveler for the finished medical devices. Yes, it “documented evidence” a finished medical device has been manufacturer in accordance with its DMR. However, it also contains the extremely important traceability data. If a product “recall” (the doctor’s favorite 6-letter word) becomes necessary, it will be a nearly impossible task to identify offending devices if the DHR does not have adequate and accurate traceability. Additionally, no CJO in his or her right mind wants to sit across from the FDA investigator if their documented evidence of compliance is less than robust. Moreover, if your organization is on the receiving end of a 483 or warning letter, please if you do not take anything else away from this week’s guidance; please provide the FDA with objective evidence the compliance issue has been corrected. Simply stating; “My bad, but we fixed the problem” is not an acceptable approach. The agency demands DOCUMENTED EVIDENCE to support the noncompliance has been corrected.
“Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. You have not established procedures for device history records. Specifically, a sample of these records was reviewed during the inspection; 40 % (6 of 15) of the records were not properly documented, either lacking required information or containing incomplete information.
We find that your March 27, 2014 response does not adequately address these deficiencies. You state that you will develop a procedural checklist but did not provide the finished document. You state you will create a log and a document to be stored in the device history record but did not provide copies of these in your response. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.”
Sec. 820.184 Device History Record
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.
Complying with regulation
Before you commence with the cursing under your breath, Dr. D knows that at times he sounds like a broken record. However, repetition can be an invaluable learning tool. Broken record time – the regulation requires device manufacturers to: “establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR.” The DHR should be considered what the doctor calls a mission-critical record. In fact, the DHR is nothing more than a compilation of all work associated with what the ISO folks call product realization. The DHR, as a minimum, should contain:
- All assembly-related travelers (completed of course);
- All records of inspection and testing;
- All deviations and the reasons behind the deviations taken;
- All non-conformances and the subsequent corrections pursued to bring the medical device back into compliance (a.k.a., rework);
- The names/signatures and/or initials of all individuals performing the work on finished medical devices and the date(s) the work was performed;
- The serial number or lot/batch number used for the finished medical devices;
- The actual quantity manufactured (quantity pass and quantity failed);
- The quantity released for distribution;
- The name, signature, and date of the individual releasing the finished medical device(s) into distribution;
- A copy of the product labeling; (a.k.a., a label retain); and
- Sterilization records.
For this week’s guidance, the doctor will leave the readers with just one takeaway. Please make the lives of your CJOs easier. There are few things in life more frustrating than sitting across from FDA, during an inspection, and not being properly prepared with documented evidence of compliance. If the DHRs are not being properly completed or maintained, rest-assured, the investigator will cite the issue as a Form 483 observation.
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.
- Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA’s enforcement page. (2014, May). FDA.gov Website. Retrieved May 9, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm395778.htm.