As many of the readers are already aware, the FDA has turned its focus and their issuance of warning letters toward the conveyors of products supporting the next generation of smoking, a.k.a. vaping. As a result, warning letters, with ample fodder for Dr. D to write about, have been slim pickings, but don’t worry. Dr. D is still able to find interesting things to write about nestled in many of the agency’s warning letters issued in 2106; for example, the handing of unsigned documents to an FDA investigator during the course of an establishment inspection. Now granted, anyone that has been through an agency inspection will attest to the fact that these can be intense and stressful events for an establishment. Employing some common sense during an inspection will always help establishments weather the inspection and hopefully emerge without any Form 483 observations. However, handing the inspector unsigned and undated documents during an inspection is almost always going to end badly for the establishment. Just ask the Chief Jailable Officer (CJO) that was on the receiving end of the warning letter mentioned in this week’s guidance. Unfortunately, for CJOs their banausic (look-it-up) daily lives are often filled with the trials and tribulations associated with working in a highly regulated industry, including visits from our dear friends from FDA. Enjoy!
Warning Letter – June 13, 2016
The establishment on the receiving end of the warning letter referenced in this week’s guidance had some issues with their approach to EO sterilization. The agency always takes an interest in product sterilization during their friendly visits for a cup of coffee and an inspection, because it wants to ensure that the establishment and their sterilization services provider are doing the right things to ensure that only sterile finished devices are finding their way into the medical device market in the United States. Pursuing practices associated with sterile load release that the agency finds questionable is always going to result in the proverbial raising of the red flag. However, handing an investigator documents that should have been signed and dated, not only is that same red flag raised high, it starts waving wildly (no wind required).
Warning Letter Excerpt
“We reviewed your firm’s response and conclude that it is not adequate. FDA considers EO sterilization processing of medical devices a significant risk process. Your firm’s response indicates the OEM is directly involved in the conduct and documentation of EO sterilization processing of the Maestro® Rechargeable System and that procedures and production records will be revised. However, the response did not include documentation to this effect. In addition, your firm’s response does not address your firm’s use of the document provided to our investigator that has no signature of an approving individual(s) or the approval date.”
Compliance for Dummies
Depending on the size of an establishment, they may not have the resources (personnel or fiscal) to establish a robust backroom during an agency inspection. However, documents being presented to the FDA need to be reviewed quickly prior to the handing of such documentation to the investigator. In a perfect world, all documents are signed and dated (as appropriate). Unfortunately, Mr. Murphy is alive and well in the medtech industry and occasionally raises his head at the most inappropriate times, such as during inspections and audits. That is why it is so important for establishments to have an individual with the appropriate skill set reviewing all documents prior to bringing them into the audit room. Otherwise, the chances of giving the FDA either an incorrect document or one with missing dates and signatures may find its way into the hands of the investigator. Additionally, Dr. D is not proposing to do something unscrupulous such as signing and back-dating a document. An unsigned document should be signed with the current date and an annotation explaining why the document was not initially signed and dated when reviewed and “approved.” You may want to consider scripting a brief memo and attaching it to the document if the individual tasked with reviewing, approving, signing and dating the document is not available or has left the organization. Regardless, handing unsigned and undated documents to the FDA is always going to end badly. One document may or may not be an issue; however, with multiple unsigned and undated documents the CJO can expect to receive a Form 483 observation. Why? If you need to ask, it is because the lack of signatures will be viewed as a systemic issue by the investigator.
For this week’s guidance, the doctor will leave the readers with just one takeaway. It is not acceptable to hand an unsigned and undated document to the FDA during an inspection. Best practice is to establish a backroom so all documents can be reviewed prior to entering the audit room. However, if an establishment does not have the resources to establish a backroom, one individual should be given the responsibility for reviewing documents prior to sending them into the audit room and placing them into the hands of the FDA investigator. Only you can prevent Form 483’s (thank you, Smokey the Bear). In closing, thank you again for joining Dr. D, and I hope you found 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. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Oscor, Inc. Accessed October 18, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm509968.htm.