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FDA “Live Review” Inspection of Company Documentation: Are You Ready?

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FDA “Live Review” Inspection of Company Documentation: Are You Ready?

The following was included in our July email newsletter.

There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management is a “headliner” on the agendas of industry trade association meetings. And of course, there are numerous industry experts who consult and advise companies on how to manage FDA inspections as one of their key offerings.

Times are changing though. The FDA is adding a new, modern approach to its arsenal of approaches for conducting site inspections. This change is not a subtle change – it is a significant change.

Traditionally, FDA has conducted detailed, paper-based reviews. Requested documentation was presented to FDA by the company in hard-copy format. Timely retrieval and presentation of documentation and data by the company to the Investigator has been, and continues to be, a critical-to-quality attribute of a successful inspection.

To ensure timely and accurate presentation of documentation and data, many companies have developed an extensive “back room” process to retrieve and review documents requested by FDA prior to presentation in the front room. This process often includes a “pre-review” and “dress rehearsal” with the individuals presenting the documentation. A recent addition to back-room / front-room communications includes the use of computer-based tools (IM / chat / screen presentations) to enhance communications and document availability responsiveness.

The Live Review: New, Modern FDA Inspection Technique

Recently, I had the opportunity to participate first-hand in a different type of FDA inspection. Having directly managed (and saved) many, many critical FDA inspections, I know what to expect, and how to lead and manage the inspection process. However, when the detailed document reviews began, the traditional process of hard-copy record review was circumvented when the FDA Investigator requested a “live review” of the documents contained within the IT system deployed by the company to manage documentation for one of its core quality sub-systems. In this case, the Investigator was reviewing the complaint process. As part of the “Live Review”, the Investigator:

  • Requested an electronic copy (on a memory stick) of the summary tables for the past x years of product quality complaints for “y” products; and
  • Requested the ability to randomly select specific complaint documentation to review “live” on the company’s computer system.

What You Can Do

This new approach to FDA inspections is likely to occur with increasing frequency. Because of this, now more than ever, exceptional writing skills are essential for all levels of the Quality organization to ensure quality records and other compliance-implicated documents stand on their own – successfully – during a Live Review inspection. Because the Live Review inspection approach bypasses the traditional “managed approach” to FDA inspections, direct actions during the inspection to improve inspection outcomes are limited. There is little to no opportunity to “verbally augment” the written record during a Live Review inspection. Your compliance documents need to be written, reviewed and approved with this new, potential inspection approach top of mind.

During numerous client engagements, Compliance Architects® has identified that writing skills for compliance implicated documents are deficient. This lack of skills leads directly to poor inspection outcomes, since quality records are the source of FDA’s determination of a company’s compliance status. However, every company can take action to ensure your quality records meet FDA expectations, and provide a complete and thorough story of compliance for Investigators to review. To find out more about the problem of compliance writing, and how you can improve your FDA inspection outcomes, please visit our Writing for Compliance® website.

FDA’s new approach to inspecting quality system documents and quality records will, over time, substantially change the traditional company inspection management process, reducing the importance of the “back room” and creating more uncertainty during inspections. For additional insight into FDA’s Live Review inspection approach, download our white paper. To find out more about our experiences with this new approach, please contact me, Teresa Gorecki, at teresa.gorecki@compliancearchitects.com, or call me direct at 310-465-7285.

Teresa Gorecki
Practice Director
Compliance Architects LLC

FDA’s Inspectional Authority: Inviolate or On Shaky Ground?

I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder  (from his firm’s excellent FDALawBlog) surrounding FDA’s inspectional authority and whether that authority is “evolving” due to recent Supreme Court decisions. Please see the interesting analysis of Mr. Fleder here:    http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/06/must-fda-regulated-companies-allow-fda-to-conduct-warrantless-inspections-1.html

My comment posted to LinkedIn is as follows:

Mr. Fleder provided a very interesting and well-written analysis of the limited numbers of cases that review and interpret the FDCA statutory basis for FDA inspections and other related statutory frameworks. For practitioners of Food and Drug law, it is a great article and something to consider as situations present themselves. However, this is NOT something that should be considered by those with operational responsibilities for inspection management, IMO. At best, forward these articles to your in-house or outside regulatory attorney with an “FYI, interesting” and leave it at that. The article presents a “what if” question of law only.

Practically, unless you are directed with good cause from your in-house regulatory attorney, or competent outside counsel, to question an FDA form 482 and FDA’s inspectional authority, it is strongly recommended that you accept that authority and permit access to your regulated facility.   As Mr. Fleder himself said in the beginning of the article:

“there is at least one subject that seems to generate universal agreement: FDA has the authority to issue a Form 482 to a companies [sic] subject to inspection under 21 U.S.C. § 374, and those companies have no right to refuse FDA’s entry to a facility.”

Failure to permit or unreasonably restrict access when presented with valid credentials and a Form 482 can result in a Notice of Refusal — and, although that is the subject of another discussion — that is something that you don’t want to be presented with.

Smile, You’re On FDA-Camera!

FDA InvestigatorThe following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA’s authority to take photographs during inspections, in light of FDA’s new, final “Guidance for Industry on Circumstances That Constitute Delaying Denying Limiting or Refusing a Drug Inspection“, dated October 2014. The subject of the LinkedIn post was: “Lawyers question legality of photography statements in new FDA Guidance on denying, delaying Inspections. “ The post can be found in LinkedIn’s FDA Inspections Group discussion thread.

The discussions focused on what to do or what to consider when an FDA investigator attempts to take a photograph. A number of comments mentioned having appropriate procedures in place to direct inspection conduct. A few comments in the thread addressed the FDA’s authority to take pictures during inspections. My comments to the thread are as follows:

[su_quote]Tread carefully here. Although it is certainly important and strongly advised to have procedures for inspection management, the thought that you can possibly procedurally “restrict” an FDA’ investigator’s lawful activity through procedural development is dangerous at best. Imagine for a minute that you had a procedure that stated that, e.g., “no third party may view manufacturing operations other than during a period from 11 AM to 1 PM”, or, that “no-one except fully-trained, full-time employees of Company are permitted in the manufacturing areas.” Clearly these are in conflict with FDA’s statutory authority, and reliance on these for non-access would be, well, not very smart. The question here is: do the applicable statutes and interpreting case law, along with notice and comment rule-making, along with this Guidance, provide FDA with the authority to take pictures during inspections? FDA clearly thinks it does. Current caselaw is based on situations outside of the FFDCA. I heard a recent statement at the FDAnews Inspections Summit by the FDA that they are itching for a fight on this, and would welcome a legal challenge — which would actually solidify their authority and probably make the practice much more prevalent.

My personal opinion and recommendation on this is the following:

  • Choose your battles with an Investigator — is this picture they want going to reveal State secrets? Honestly, there’s often not much exciting in manufacturing pictures that are of much use to anyone competitively, IMO.
  • Ask the investigator WHY they want the picture — what point — deficiency — are they trying to document? What system or practice are they concerned about. Where does this fit in their overall set of concerns. Ask them if there is another way you can help them with their objective WITHOUT taking a picture. Understand their needs, that a picture may be worth a 1,000 words, and perhaps this is not a big deal.
  • Look at the subject of the picture objectively and understand the underlying issue and the context of the inspection “atmosphere” to that point. Are they “gunning” for a significant enforcement action, or is this really just to help the Investigator do their job. Don’t make a big issue about something that isn’t a big issue.
  • Allow them to take the picture (since they likely have the authority to do so IMO) and make sure you take an exact copy of the picture (request they provide you with a copy) with your own camera for later assessment and analysis of significance.
  • Finally, make sure you have reviewed this information with counsel BEFORE an inspection occurs and understand their best recommendations as to what to do in the event of an issue. This is not 100% settled law (otherwise we wouldn’t be discussing it), so your counsel’s advice is critically important.

Good luck, and be careful out there… [/su_quote]

For assistance with this andother challenging aspects of FDA inspections management, please contact Jack Garvey at john.garvey@compliancearchitects.com or at 888-REG-XPRT.

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