Welcome to the first installation of Warning Letter of the Week (WLOTW). Each week, we will review a different FDA Warning Letter, to gather as much information as possible to avoid repeating those mistakes. The Warning Letters will range from recently posted letters to letters covering specific markets, and anything else I find interesting.
If you are curious to find out more about Warning Letters, check out FDA Warning Letters: Everything You Need to Know.
For the first week, we will look at the medical device industry and review a Warning Letter for Forcemech International LLC (full Warning Letter).
Based on the letter and their Amazon page, it looks like Forcemerch imports, repackages, and distributes electric wheelchairs.
The Warning Letter starts by firmly stating that Forcemech is a med device manufacturer and distributor of two specific electric wheelchairs. It also explains that the devices are adulterated due to a large number of violations of 21 CFR Part 820. Let’s look through the violations to understand the extent of the issues.
If you want to skip to the actionable items found in the Warning Letter, skip to the Lessons Learned section below.
Table of Contents
Failure to Maintain a DMR and Labeling Procedures
The first violation is that Forcemech did “not adequately established procedures to maintain (their) device master record (DMR), which shall include, or refer to the location of, information regarding (their) packaging and labeling specifications used to identify (their) powered wheelchair.”
The letter explains that Forcemech used a “10-digit alphanumeric random serial number… which is not compliant with (UDI) regulation, 21 CFR 830.”
Here we can see two major mistakes. The first is that Forcemech failed to create proper labeling specifications. Specifically, they did not define how their serial number would be identified, or the coding system for the letters and numbers.
The second mistake is that Forcemech did not use proper formatting for their UDI. The information about the UDI is repeated several times throughout the Warning Letter. If you were not aware, you are not allowed to use any randomly generated code and have it be considered a UDI. You must follow specific FDA guidelines listed in 21 CFR Part 830 and related labeling regulations.
These mistakes are a theme of the Warning Letter. Being that the company’s activities (in terms of medical device regulations) are mostly related to relabeling parts, this makes a lot of sense.
Failure to Establish Acceptance Activities
The next violation was that Forcemech did not establish proper acceptance and inspection activities for receiving the devices. Specifically, the “firm’s Final Acceptance Inspection procedure” was not in line with the “criteria listed in (their) Product Inspection Form”.
The letter then details specifically what was missed from the inspections: “checking for sticker integrity, verifying the condition of all product accessories, verifying the manufacturer’s quality control records, and verifying the condition of the product manual and version. Your procedure fails to describe the process for assigning internal lot numbers for new products and the method used for tagging the lot to signify that the lot can be used for shipment.”
Based on how the article is written, it looks like the company is checking most of these elements during their incoming and returned parts inspection. The FDA explains that this information is included in the specific “Product Inspection Form”.
As seen above, the main issue leading to this violation is that inspection/acceptance activities that were taking place were not properly specified in the Inspection Procedure. There was also no definition for how the internal lot numbers of devices would be defined.
Failure to Control Documents
This next violation is intensive and includes many different examples of how Forcemech did not properly control documents.
- “Labeling changes to User Instruction Manuals” were not maintained.
- The firm “did not maintain adequate revision history of (its) user manual content changes or revision updates”
- The “(DMR) did not include documents such as labeling artwork (logos) and product labeling”
- “There was no label control procedure”
- Finally, the “Document Control procedure does not include detailed descriptions of the change(s) made to control documents, as well as the reason for the change.”
Forcemech failed on very standard document control activities. They did not properly maintain documents or labels and there was no procedure for controlling labels. The DMR did not include necessary documents, such as product labeling.
In short, the document control procedure was not adequate. Forcemech did not have necessary doc control procedures in place, and there were fundamental aspects missing from the procedure.
Basic document control states that you should include descriptions of the changes you are making to documents and list the reasons for those changes. This is information commonly found on the revision history page of properly controlled documents.
Failure to Establish Servicing Procedures
This is an interesting part of the Warning Letter. While the other violations could be found in the quality management system of most companies, the servicing requirements are more unique to specific devices.
To sum up the Warning Letter, the FDA inspector observed that Customer Service reps were troubleshooting customer complaints over the phone. The CS staff was attempting to resolve technical issues, sending videos to customers on how to correct concerns, and sending replacement parts to customers.
The violation is concluded by stating that the “quality system procedures fail to include the process for distributing/installing replacement parts, entering and tracking the information and results to completion, and analyzing the data, such that your firm could demonstrate proper installation of replacement parts.”
There are a lot of different issues rolled into one for this violation. Forcemech most likely did not have good enough servicing, but I’m wondering if they were also lacking in their complaint handling (this is just a guess, and was not cited in the Warning Letter).
If customer service reps are just giving advice over the phone and sending replacement parts without tracking the outcome, they are likely not recording all information correctly.
Therefore the company did not have enough data to justify that the servicing activities were successful. If they had properly recorded and analyzed the data, they may have been able to continue the servicing in that manner. They would have needed to document the entire servicing process and show the servicing could consistently lead to a successful fix.
Failure to Properly Label Repacked Devices
The final violation we will discuss should be of much interest to repackagers and re-labelers of medical devices.
The FDA inspector found that wheelchairs that were repacked on-site did not have a new UDI placed on the devices. The devices were labeled with one of the randomly generated numbers seen in the first violation, but this was not considered a UDI.
What may be interesting to companies who relabel devices is what the violation was cited under. From the FDA: “per 21 CFR 830.50(b), whenever you create a new device package, you must assign a new device identifier to the new device package; and per 21 CFR 830.60(a), if you relabel a device that is required to bear a UDI, you must assign a new device identifier to the device.”
Lessons Learned
Here, we will summarize the main takeaways from the Warning Letter. As mentioned, the goal of the Warning Letter of the Week articles is to help you see what mistakes lead the FDA to generate Warning Letters and learn how your company can avoid those mistakes.
- Ensure the UDIs you are using for devices are in compliance with FDA formatting regulations and reference this information in your Device Master Records.
- Labeling procedures should include the coding system of the UDI and how different devices will be labeled.
- Make sure your forms match your procedures. This is a broad lesson that applies to every process in your QMS. In this circumstance, the company’s Final Acceptance Procedure did not include all of the necessary elements found in its Product Inspection Form.
- Establish document control procedures. This is a fundamental requirement of any QMS. Without document control, there will always be issues and concerns raised from documents with limited information. For Forcemech, the labels were not properly controlled, and there were missing descriptions of changes found in procedures.
- Get a full understanding of what your requirements are if you are going to be servicing devices. In this situation, a violation was generated because CS reps were helping customers fix issues over the phone. They were not properly recording whether the solutions were done correctly or if they addressed what was needed. If you are going to have customers try and replace parts themselves, you need a significant amount of data to demonstrate the proper installation of parts and need to track the process from beginning to completion.
- If you are creating a new device package for a device that is required to bear a UDI, you must assign the device a new UDI. The new UDI should also be traceable to the original UDI: 21 CFR 830 for reference.
Wrapping Up
That was our introduction to WLOTW, with the FDA Warning Letter for Forcemech. Hopefully, you were able to glean some new thoughts or insights from this post. If you want to help avoid similar issues, check out our blog, which has detailed guides on how to write ISO 13485 and FDA-compliant procedures.
As always, if you have any questions or thoughts on this Warning Letter, feel free to leave them in the comments below.