During Dr. D’s weekly visit to the FDA’s warning letter database, he was surprised at how quickly he was able to stumble upon another award-winning device establishment worthy of an agency warning letter. Not having written procedures, as required by §820.20(e), is always going to end badly for the offending establishment. Couple a seven-observation warning letter, with a failure to respond to Form 483 observations and the entering of product into interstate commerce that has not been cleared in accordance with 21 CFR, Part 807, and seriously bad things are going to happen. Not having the appropriate procedures in place can be quickly remedied with some good-old fashion hard work. However, not responding to the FDA’s inspectional observations or the incorrect classification of finished medical devices, resulting in the entering of product not cleared by FDA through the 510(k) process is a monumental screw-up. The Chief Jailable Officer (CJO) should probably be banished to the toy industry. If this monumental screw-up is premised on not having a CJO, now is the time to consider hiring one! Dr. D’s philippic (look-it-up) for this week will shed some light on what happens when an establishment implements bad quality, regulatory and statutory practices. Enjoy!

Warning Letter – November 19, 2015

“You can’t make this stuff up” is quickly becoming one of the doctor’s favorite mantras. In fact, Dr. D has to ponder the question, what took the FDA so long to elevate the regulatory pain on this offending establishment? The inspection was in March of this year and the failure to respond to FDA probably occurred in early April. The agency took eight months to issue the warning letter, after the initial transgression, a failure to respond to the Form 483 observations. Now granted, device establishments are not required by law to respond to Form 483 observations. However, if no response is provided to the agency within 15 days, someone should start cranking out the warning letter. There is nothing that tells a device establishment to stop and fix their quality, regulatory and statutory issues faster than the agency warning letter. Well maybe, U.S. Marshalls with chains and padlocks might be a nice touch if a stronger message needs to be sent. Heck, even backing up the old turnip truck, to collect violative inventory, sends a nice message to offending establishments.

Warning Letter Excerpt

Introductory Paragraph Extraction: “To date, we have not received a response from you concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.”

Observation Seven: “Failure to establish Quality System procedures and instructions as required by 21 CFR 820.20(e). For example, your firm’s management did not sign or date the Quality Manual, (b)(4); Investigations of Complaints, (b)(4); or Corrective and Preventive Action System, (b)(4). In addition, your firm could not provide copies of the following procedures listed in your firm’s Quality Manual: Device Master Record, (b)(4); Supplier Evaluation and Monitoring, (b)(4); Production Work Order and History Record, (b)(4); Product Identification and Traceability, (b)(4); Labeling and Packaging, (b)(4); In-Process Inspection, (b)(4); Final Acceptance Inspection, (b)(4); and Measuring and Monitoring Equipment, (b)(4).”

21 CFR, Part 820.20 – Management Responsibility

(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.”

Compliance for Dummies

Premised on the warning letter observations, even a regulatory novice can quickly ascertain that issues with the Quality Management System (QMS) were readily apparent for this establishment. Now granted, failing to sign and date the quality manual (note: not a QSR requirement to have a quality manual) or a couple of procedures is not a serious infraction—it could be viewed as a lack of managerial oversight. However, failing to have a device master record (DMR) or other relevant procedures established, which are needed to place finished medical devices that are safe and effective into commerce, is always going to be viewed as problematic.

For some device establishments, the problem is rooted in a failure to understand the differences between quality and regulatory requirements for Class I and Class II devices. For some reason, there is a perception that “special controls” equates to not having a QMS requirement. People, that perception could not be further from the truth. Just ask the CJO associated with this week’s offending establishment. Wait, they might not have one!

Dr. D is sure many of the readers will want to heap contumely (look-it-up) on the old doc for this next comment. If a device establishment wants to play in the FDA’s sandbox, take the time and establish a QMS that is compliant with all of the appropriate sections of 21 CFR Part 820 (the QSR). For sections of the QSR that do not apply, the doctor recommends writing a brief procedure (one paragraph) that clearly delineates the reasons certain sections of the QSR do not apply.  The doctor can already feel the contumely!

Additionally, the doctor strongly recommends performing, at the very least, an annual review of all procedures to ensure the procedures are effective and reflect current quality, regulatory and statutory requirements. Yes people, standards and regulations are dynamic and do change from time to time (i.e., requirements for eMDR, UDI, etc.). For establishments that enter product into commerce in the European Union, big changes are coming in regards to the new MDD regulation. In fact, so many changes are coming out of Europe that it will make your head spin.

Takeaways

For this week’s DG, the doctor will leave the readers with three takeaways. One: Always respond to FDA Form 483 Observations! Please do not be that establishment that fails to respond to the agency’s request for corrective action. Bad things will happen. Two: It is Dr. D’s humble opinion that establishing a QMS that fully complies with the QSR is considered a best practice. Three: Always ensure that you properly assess the use of Class I for finished medical devices. Failure to do so could result in product that should potentially be Class II being introduced into commerce without obtaining clearance by the FDA. When in doubt, call FDA and ask. 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

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. (November 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed November 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm