Only Two Form 483 Observations Can Equate to a Warning Letter
Did you miss old Dr. D last week? Finally, the doctor was able to take his first real vacation since starting Devine Guidance International, Inc. in 2011. Central America was a blast (Dr. D would like to add). Now it is time to get back to the business at hand, writing about quality and regulatory compliance, while employing examples of device establishments that have run afoul of FDA as learning tools, so the same bad things do not happen to your organizations. As hinted at in the title of the week’s guidance, an establishment does not need to rack up a large number of Form 483 observations to earn a prestigious (maybe not so much) agency warning letter. Two observations and a failure or refusal to provide an FDA inspector with requested information and a warning letter will be in an establishment’s future. There is no crystal ball required to see if something bad is about to happen. Obviously, the Chief Jailable Officer (CJO) associated with this week’s offending establishment was eager to join the refractory (look-it-up) group of CJOs that find alienating the FDA enjoyable. Unfortunately, FDA has the ability to unleash a plethora of regulatory pain on establishments that fail to comply with the Quality System Regulation (QSR). Enjoy!
Warning Letter –July 30, 2015
One surefire way to tick off the FDA is the failure to develop (establish) procedures for complaint management and Medical Device Reporting (MDR). Regardless of device classification, the expectation is that device establishments evaluate product complaints and file MDRs when deemed appropriate. Now considering the establishment that is the focus of this week’s guidance had no procedures for these activities, Dr. D is going to climb out on that proverbial limb and assume they were not taking complaints from customers or filing MDRs. Folks, the doctor would like to reiterate that not investigating complaints or filing MDRs are considered bad things by our friends at the agency. Who knew?
Observation One (1) – “Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, for the cutaneous electrode garment device that your firm initially imports, procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.”
“We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include any information to demonstrate that a Complaint Handling procedure would be established by your firm.”
Observation Two (2) – “Our inspection revealed that your firm’s cutaneous electrode garment devices, which you initially import, are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant violations include, but are not limited to, the following: Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, for the cutaneous electrode garment device that your firm initially imports, your firm does not have any written MDR procedures.”
“We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include any information to demonstrate that a MDR procedure would be established by your firm.”
Compliance for Dummies
The requirements for complaint management (21 CFR, Part 820.198) are fairly robust and detailed in the QSR. However, FDA makes one salient point extremely clear: Manufacturers are required to establish a procedure for complaint management. The procedure shall delineate how a device establishment receives, reviews and evaluates complaints. Additionally, all complaints shall be processed in a uniform and timely manner. Simply stated, do not take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint evaluation process, device establishments shall determine if the complaint is a factor in an adverse event that is required to be reported as a MDR in accordance with Part 803 requirements.
Similar to complaints, device establishments are required to establish a procedure for reporting adverse events as MDRs, when deemed appropriate. Part 803 provides a succinct view of what the agency expects to see in an MDR procedure. Dr. D strongly recommends cutting and pasting as much of Part 803 as possible and using it as the framework for your organization’s MDR procedure. Please note, as of last week (August 14, 2015) the use of eMDR reporting formally went into effect. Dr. D strongly suggests becoming familiar with the FDA’s eSubmitter Program. Enjoy using the program, as it is Dr. D’s opinion that the software is not overly user friendly. However, with experience, the use of the software does get easier.
Takeaways
For this week’s guidance the doctor will leave the readers two takeaways. One: Regardless of the device class, FDA expects device manufacturers to have established procedures for complaint management and MDRs. Rest assured, the FDA will visit these areas when they magically appear at your establishment’s front door for a cup of coffee and an inspection. Two: As of August 14, 2015, eMDRs became a mandated reality. It is in your organization’s best interest to become familiar with the eMDR process and the use of the eSubmitter software. 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.
References
- Code of Federal Regulation. (2014, 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.
- 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’s enforcement page. (July 2015). Accessed August 17, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm457229.htm
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