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Jan 17, 2017

Preparing for a US FDA Medical Device Facility Inspection

by Linda M. Chatwin, Esq. RAC


Manager Medical Regulatory Advisory Services


North America UL, LLC



First in a series of articles about how to prepare proactively for an inspection, how to prepare after the call that the inspection is imminent, and how to react during and after the inspection.

It is never fun to get that call – the one where the FDA lets you know they will be at your facility in a few days to give an inspection.

There are a number of things that once can do to be more prepared for that day, however, and preparation is key in minimizing not only the stress of the inspection, but also the outcome of it.


FDA has a Transparency initiative, where they publish the findings from the previous year inspections. The idea that FDA had for establishing this initiative, was that it would help manufacturers to be able to see the areas of most findings, to help with their own systems.

Following is an analysis of types of findings from FDA’s data for the year 2015. Of course, 2016 is not yet available; however, the information is still meaningful for a company to study with respect to their own systems. These are not all inclusive; there are other areas in which findings are made.

Source: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf

CAPA


Section
Title/Subject
Number
Percent
820.100(a)
Corrective and Preventive Action procedure requirements
381
34%
820.198(a)
Complaint files requirements
330
29%
820.90(a)
Control of nonconforming product
157
14%
820.100(b)
Documentation of CAPA actions
90
 8%
820.198(c)
Requirement to review possible failures
58
5%
  

Production and process controls 


Section
Title/Subject
Number
Percent
820.75(a)
Process validation requirements
180
16%
820.50
Purchasing controls
141
12%
820.72(a)
Control of inspection, measuring and test equipment
76
7%
820.70(a)
Production and process controls
68
6%
820.80(d)
Final acceptance activities
66
6%
820.80(b)
Receiving acceptance activities
58
5%



Design controls 


Section
Title/Subject
Number
Percent
820.30(g)
Design Validation
171
32%
820.30(i)
Design Changes
87
16%
820.30(f)
Design Verification
76
14%
820.30(e)
Design Review
50
9%
820.30(a)
Design Control Procedures and Process
36
7%
820.30(j)
Design History File
30
6%
 


Management controls 


Section
Title/Subject
Number
Percent
820.22
Quality Audit – Internal planning and process
145
38%
820.25(b)
Personnel – proper training procedures and records
85
22%
820.20(c)
Management Review
75
20%
820.20(b)
Organizational chart and responsibilities
25
7%
820.20(e)
Quality System procedures
20
5%

 

Using the information


Armed with the knowledge of where the highest findings are, a company can concentrate their internal resources into analyzing their processes in these sections of the Quality System Regulation. A variety of actions can come from this:
  • Compare the company’s quality system against the FDA QSR requirements. Remember to check the guidance documents, as well, as a wealth of information about FDA expectations can be found there.
  • Conduct internal audits – and think about engaging an outside party for a fresh look – to ensure that both the QSR requirements and the internal quality system requirements are met. Concentrate in the areas of the highest findings. By the law of large numbers, this is a good tactic for a company to follow.
  • Review internal audit methods and checklists against the FDA QSIT manual. Internal auditors should follow this method as well as the typical ISO audit checklists to maximize efficiency.
  • Review internal audit findings – does the same issue recur in the internal audits? If so, do some detailed analysis about why this occurs.

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To thine own self be true - Shakespeare


Remember, even though FDA is not entitled to inspect internal audit reports nor Management Reviews, they can learn about the issues through the CAPA process. It is vitally important to do a good job with root cause analysis and monitoring for effectiveness of actions, so that the same issues do not continually recur. 

By not reviewing these internal processes, FDA intends that manufacturers will be forthright with themselves and take honest and hard looks at their internal processes, being candid in internal audit reports and monitoring the actions for effectiveness. However, if FDA finds quality trend issues in the complaints, CAPA, production and process control and design control processes, it can easily lead them to the company graveyards where the bones are buried. 

Is there really a difference between ISO and FDA?


Some companies believe that conformity to ISO 13485 will be sufficient to successfully pass an FDA inspection. This may become truer in the future – with the recent updates found in ISO 13485:2016. Also, with the move towards the Medical Device Single Audit Program (MDSAP), audit techniques will more closely match. However, for now, the requirements and expectations are somewhat divergent. Therefore, companies would be well advised to closely prepare using the tools discussed above.

Other areas to prepare for an FDA inspection include:
  • Ensuring that the company’s establishment registrations and device listings are correct and up to date, including each manufacturing facility location. 
  • Reviewing complaints to ensure that analysis for Medical Device Reporting  (MDR) has been properly conducted
  • Ensuring that MDRs are made as required
  • Reviewing service records for the actions to be taken with respect to possible complaints and/or corrective and preventive actions
  • Trend analysis of complaints also with a view towards whether CAPAs are indicated


New requirements and focus areas


And now we have the Unique Device Identification (UDI) requirements. This area of new rule from FDA presents substantial complication in the life of medical device manufacturers. The rule contains a number of requirements, which are being implemented at different timelines over the next few years. During inspections, FDA will undoubtedly be checking for compliance to these requirements. They will also be looking for compliance to other performance standards, such as the radiation emitting standards, which have not always been a subject of inspection activities in the past.

Not necessarily new, but more compliance emphasis being placed, includes appropriate marketing clearance for the products that a company markets. This is a required element in the UDI rule, known as the GUDID, or Global Unique Device Identification Database. Here, each device that a manufacturer provides, must be entered into the database, including by what clearance pathway it is marketed. As we know, products are considered to be misbranded if they are not properly cleared for market, or if their labeling is not compliant with the labeling regulations. Devices are considered to be adulterated if the quality system is not in compliance with the QSR requirements.


Other areas


Some other areas to pay attention to during inspection preparation activities:
  • Corrections and Removals – are any of the company’s products needing to have corrections that can be done in the field, or removal from the market? Pay attention to the record keeping and reporting requirements in these cases.
  • Part 11 compliance – if the company uses electronic signatures, are they properly applied and validated? Are electronic records kept and under appropriate controls?
  • Medical Device Tracking, where applicable.


Final thoughts


Preparing for an impending FDA inspection requires a well-organized program, and this is vital to a successful outcome. Many valuable lessons will be learned during the preparation process. It will require specific teams and assignments to do the project justice – and again, considering use of an outside resource to help identify gaps can be a valuable tool to eventually avoid receiving a Warning Letter.

So, are you ready?



Linda Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is an attorney in the U.S.  She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues. 




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