Folks, before you start slamming Dr. D for revisiting a topic that he has covered multiple times previously, the doctor felt compelled to talk about complaints after reading this particularly egregious warning letter that placed a spotlight on the perils associated with the mismanagement of the complaint management process.
For starters, device manufacturers should actually be listening when a customer calls with a complaint. Ladies and gentlemen, although being on the receiving end of a complaint is never pleasant, your customers are trying to tell you something; “YOUR FINISHED MEDICAL DEVICE DOES NOT WORK AS ADVERTIZED!’ Instead of device manufacturers sticking their proverbial heads in the sand and worrying about product sales, they need to stop with the resorting to “hagiography” (look-it-up) and the pursuit of the almighty dollar. People, you can believe what you want but rest assured, when your friends from the agency show up on your doorstep for a cup of coffee and an inspection, they will eventually find their way into your complaint system.
Wait just a minute Dr. D, what happened to QSIT and CAPA plus one? If your complaint management system is in compliance with 21 CFR, Part 820.198, then complaints should be feeding your CAPA system. If they are not, then guess what friends, you have problems and soon you will have an even bigger problem, FDA and a potential warning letter. That being said, the doctor hopes you enjoy this week’s guidance.
FDA Warning Letter Dated – 07 March 2014
In the fall of 2013, FDA spent about six weeks at Hospira’s Rocky Mount, NC facility for an inspection. It must have been the great food, booze, and hospitality that kept the agency around the town of Rocky Mount for a span of 47 days. However, the doctor thinks it may have been the complaint management system. Regardless, the fruit of FDA’s efforts was a tersely-worded warning letter that included two Form 483 observations against complaint management, or lack of, if you read the warning letter. Equally impressive was FDA’s “your response fails to address” comments cited in the warning letter. Dr. D has taken the liberty to extract and paste a copy of the observations pertaining to complaint management for your reading enjoyment.
“3. Records of complaint investigations do not include required information in accordance with 21 CFR 820.198(e). Specifically, Sterile Empty Vial lot (b)(4) was manufactured from the same parent lot found to contain embedded particulates, which resulted in a product recall. Prior to the current inspection, the firm has not reviewed Lot (b)(4) to determine if there is any quality impact to the distributed Sterile Empty Vials (medical devices).
In your response letter, your firm indicates that no quality impact was determined during your investigation regarding this observation. However, your response fails to address the use of a component (which resulted in a recall in your drug product) in your Sterile Empty Vial lot (b)(4).
4. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established in accordance with 21 CFR 820.198(a). Specifically, Complaint PR 1613935 awareness date 2/21/13, PCA Empty Sterile Lot (b)(4), is currently open and there are no extension requests or status reports for the complaint.
Your response fails to adequately provide justifications form complaint PR 1613935 remaining open. Please provide an update on the status of this complaint.”
Complaint Files 21 CFR, Part 820.198
(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
(1) All complaints are processed in a uniform and timely manner;
(2) Oral complaints are documented upon receipt; and
(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis; and
(3) The relationship, if any, of the device to the reported incident or adverse event.
(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
(f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.
(g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:
(1) A location in the United States where the manufacturer’s records are regularly kept; or
(2) The location of the initial distributor.
Complying with the regulation
The doctor is going to let you in on a tiny little secret that is nestled in §820.198 (a) (1), the first key word is “TIMELY” manner, as in not waiting until the cows come home to open and complete a complaint investigation. Additionally, complaint activities must be “DOCUMENTED” as in documented in writing or some other form of print that supports the availability of objective evidence. Furthermore, complaints must be assessed for the need to “REPORT” as in reporting adverse events in accordance with 21 CFR, Part 803 (Medical Device Reporting). Moreover, regardless of whether a complaint will warrant a MDR, all complaints must be “INVESTIGATED” as in determining the root cause of the problem the resulted in a complaint. If a decision is made not to investigate a complaint, written “RATIONALE” must be proved to support the decision not to investigate.
Finally, it makes good business sense to provide a written “REPLY” to all complainants. A well written and contrite response to the complainant will definitely smooth over some ruffled customer feathers and result in some good karma being placed in the medical device karma bank. Otherwise, rest assured your competitors will be knocking on your customer’s door informing them of the great news; “guess who just got a warning letter?”
For this week’s guidance, the doctor will leave each of the readers with a unique takeaway, some salient words: (a) timely; (b) documented; (c) report; (d) investigated; (e) rationale; and (f) reply. Being bright and perceptive device industry professionals, Dr. D is sure you can connect the dots.
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 803: Medical device reporting. 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, April). FDA.gov Website. Retrieved April 10, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390797.htm