As many of the readers already know, Dr. D loves to make fun of his favorite little nasty word. Get your minds out of the gutter folks—the word is “recall!” It is not often that the doctor stumbles across an issue with executing a correction or removal, the gentler way to say, “recall”. However, there is always going to be that one device establishment that fails to comply with the finer points of Part 806, like all of it. This week’s offending establishment, on two occasions, failed to notify FDA of a correction or removal (recall). In fact, the recall occurred outside of the United States but after rework, the product was entered into commerce in the country. Nice. Dr. D would have loved to see the stolid (look-it-up) expression on the Chief Jailable Officer’s (CJO) face after the investigator awarded this offending establishment with nine Form 483 observations. Obviously, the receipt of nine Form 483 observations for any device establishment usually ends badly. And failing to notify FDA in accordance with Part 806 requirements will end badly as well. Enjoy!
Warning Letter – May 16, 2016
As mentioned in the introduction, this week’s offending establishment received nine Form 483 observations for a multitude of compliance issues associated with its quality management system (i.e., CAPA, supplier management, design control, complaint management, medical device reporting), and the subject of this week’s guidance, RECALLS. All recalls, regardless of Class, shall be documented; and just maybe, the CJO might want to consider notifying our friends at the agency that a recall is in the works. The following FDA definitions can be used to gage and assign the correct class for a recall:
- Class I: reasonable likelihood of serious adverse health consequences or death;
- Class II: temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
- Class III: not likely to cause adverse health consequences.
Warning Letter Excerpt
Observation Nine (9) – “Failure to submit a written report to FDA of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. For example:
a. In 2013, after complaints of a higher than normal positivity rate, your firm conducted a product recall of TB antigen tubes, lot A1210004, Nil Tubes, lot number Al210008, and mitogen tubes, lot number Al210006, in Japan. Your firm documented that elevated TB values are known to be caused by the presence of endotoxin in tubes. The endotoxin levels ranged from (b)(4), some of which exceeded the manufacturer’s specification. Your firm did not submit a Report of Correction or Removal to FDA.
b. In 2014, after complaints for (b)(4) of TB3G ELISA lot 059452521 were returned from Japan. Your firm attributed the issue to (b)(4). The devices were reworked, and then distributed in the US. Your firm did not submit a Report of Correction or Removal to FDA.
We reviewed both of your firm’s responses, and conclude that they are not adequate. Your firm should be aware that all products manufactured in the U.S. are subject to 21 CFR 806. As of April 13, 2016, there is no record of Qiagen submitting a Report of Correction or Removal to FDA for these two medical device removals.”
21 CFR, Part 806.10 – Reports of Corrections and Removals
“(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).
(b) The manufacturer or importer shall submit any report required by paragraph (a) of this section within 10-working days of initiating such correction or removal.”
Dear readers, Section 806.10 is quite verbose, so you can obtain the balance of this section on FDA’s website, on the “CFR – Code of Federal Regulations Title 21” page.
Compliance for Dummies
The classification of a particular recall will define the boundaries for executing the product recovery process. Product recalls are typically voluntary; however, the FDA giveth and the FDA taketh away. If a medical device poses an imminent threat to public health and safety, the agency can order a Class I recall. Even for a device-manufacturer sponsored recall, FDA notification is required. Through the concept of “First Alert”, the FDA becomes aware of a product issue in many ways, and the clock starts ticking. Ten-working days is all the time a device establishment has to report a recall to FDA.
The FDA expects device establishments to pursue the following tasks as part of the recall process:
- Provide FDA with product-related information
- Provide FDA with product identification (lot) numbers (note: UDI is a real help here)
- Provide FDA with name of the recalling firm
- Manufacturer is different from the recalling firm
- Provide FDA with name of establishment responsible for the violation/problem
- Provide FDA with reason for the RECALL
- Provide FDA with a copy of the Health Hazard Assessment (do not reinvent the wheel, use the FDA’s form)
- Provide FDA with volume of product to be recalled
- Provide FDA with distribution pattern
- Create and issue the recall notification packet
- Provide FDA with effectiveness of recall data
- Provide FDA with recall status reports
- Provide FDA with root-cause analysis for the recall
- Provide FDA with corrective action pursued to prevent a recurrence of the problem
- Provide FDA with recall termination notification
Executing a RECALL
Right after the call is made to FDA for the initial consultation, the device manufacturer begins the arduous task of identifying where the medical devices requiring to be recalled are located within the United States (or abroad). Written notification made to each buyer of a suspect device will be required. In fact, ensure evidence of notification is collected (i.e., use FedEx, UPS or USPS to ship the recall packets and collect evidence of receipt). Just in case you are wondering, evidence of receipt equates to a signature acknowledging receipt of the recall package. In the eyes Dr. D and the FDA, the magic number is three, which equates to three attempts (good-faith effort) to collect product being recalled. Collecting the suspect devices will require significant vigilance and a recall manager with the persistence and tenacity of a pit bill—ruff, ruff! As product is returned and collected, it is imperative that the product be placed into a quarantine location, with meticulous records maintained. Once the device manufacturer is in a position to accurately determine that no more devices are going to be returned, hopefully an effectiveness rate of greater than 90%, then FDA can be contacted and plans for the certified destruction of the devices executed, or rework plans scripted and approved (including agency review). Make sure the FDA is notified when the closure of a recall is scheduled to occur. The FDA will acknowledge the closure. Once upon a time, in a distant land called California, Dr. D watched in amazement as a forklift was driven back and forth over a couple of hundred catheters in an effort to destroy them. Was it effective? Heck, yes; however, it was also quite messy. The doctor recommends contacting a firm specializing in the certified destruction of medical devices. Make sure the certificate of destruction is included in the recall documentation.
Remember, the FDA will want to look at all of the documentation associated with a recall as part of one of their friendly visits (a.k.a., facility inspection). The agency is always interested in the effectiveness of a device manufacturer’s recall efforts, regardless of the classification.
For this week’s guidance, the doctor will leave the readers with just one takeaway. RECALLS are serious events and should be managed accordingly. Dr. D considers it best practice to reach out to the agency and obtain their concurrence that the correct recall classification has been selected. Otherwise, your CJO may end up in the proverbial hot seat. 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. (April 2015). 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.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (May 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Qiagen Sciences, LLC. Accessed May 24, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501292.htm