Simply stated, “adulterated” in the eyes of the FDA means that a finished medical device is non-conforming, i.e.: (a) does not operate in accordance with its stated product specification; (b) was not manufactured in accordance with its Device Master Record (DMR); or (c) was not manufactured in an environment that complies with the QSR requirements. Pick one or pick all three. For device establishments that continue to linger in their “unregenerate” (look-it-up) ways, a surprise visit from FDA and a non-compliant QMS will likely result in their devices being identified as adulterated. It appears entering adulterated devices into commerce in the United States may result in a warning letter. That being said, the doctor hopes you enjoy this week’s brief guidance.
FDA Warning Letter – 30 June 2014
In the previous edition of Devine Guidance, Dr. D posed a question to the readers relating to how many Form 483 observations does it take to earn the prestigious FDA Warning Letter Award. For this week’s guidance, the offending establishment received only two observations. However, it should be noted that the two inspectional observations were linked to product issues in the field. Since the doctor tends to be the inquisitive type, Dr. D visited the MAUDE database and was able to locate 4 MDRs filed in 2014, for the adulterated product identified in the warning letter. Unfortunately, one of the MDRs was for the death of an infant and probably why the agency paid this device establishment a visit.
This inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System Regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
Compliance for Dummies
As stated in the warning letter selected for this week’s guidance, this device establishment failed to comply with cGMPs; a.k.a. 21 CFR, Part 820; a.k.a. the QSR. Folks, the agency cannot possibly state their concerns more eloquently. Hopefully, all industry professionals understand the need to comply with the QSR for Class II, Class III devices and on a rare occasion, a Class I device. If not, other industries beckon you and hopefully not a regulated one. Seriously, the expectation is that a fully-functional/operational QMS is available long before the first device is cleared or approved by FDA. Simply put, written procedures (where the agency states the term “establish” in the QSR) are required to be implemented (including employee training) and followed. Additionally, the agency is really big on two words “objective evidence.” It is a very uncomfortable position to be in when the Chief Jailable Officer (CJO) is sitting across from an agency investigator; and attempting to defend a QMS that is ineffective and lacks the documented evidence to support compliance. If the CJO cannot keep from laughing hysterically, chances are pretty good the results of the inspection are not going to be good. Yes, Dr. D knows he constantly harps on the need for written procedures; however, the doctor is looking after your best interests. If you do not have the required procedures, please script them ASAP or hire a qualified consultant to do so. If you take the time and search really hard, most of the procedures ever needed by a device establishment can be located during a search of the Internet. It may take some time but trust Dr. D when I say, the information is there. You just have to look for it!
For this week’s guidance, there are no takeaways just one piece of friendly advice. If your organization lacks the required procedures to support compliance with the QSR, there is no time like the present to start writing. If you do not have the resources internally, find a qualified consultant to assist with the procedure generation. 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, July). FDA.gov Website. Retrieved July 15, 2014, from