Curious about some of the common FDA 483 observations that pertain to unique device identification (UDI) for medical devices?
During the recent Redica Systems webinar, “Unique Device Identification | Aligning to a Single Approach,” GMP Medical Device Expert Mark Agostino reviewed recent FDA inspection findings in this area, bringing some answers to light.
Using Redica Platform, Agostino analyzed over 100 FDA 483 observations since 2014. Below are the seven most common FDA 483 observations involving UDI he found.
For more 483 insights involving UDI, download a recent analysis of 100 form 483s using our Expert Model. Medical device manufacturers can also contact us to learn how our actionable data intelligence can generate insights.
1. Device History Record Does Not Refer to UDI Location
“One of the more prevalent ones is that the device history record does not include or refer to a location of a UDI, so this just speaks to not having clearly identified a UDI within your records,” he said.
This observation, in particular, emerges when FDA investigators review complaint investigations involving product quality issues as the investigator will examine the device history record for that specific lot. Without the UDI information, it is a challenge to connect the issues to supporting manufacturing documentation.
2. Complaint Investigation Records Do Not Include UDI
“Here, you have the device, whatever it is, but no information to help identify what lots or what particular version of the device is in question,” Agostino said.
FDA investigators expect to see the UDI as part of complaint investigation processes.
3. Illegible UDI Label
Another UDI issue that comes up during FDA inspections is illegible UDI labels, which relate to a manufacturer’s inspection and verification processes.
4. UDI Not Carried Throughout Distribution
“This means that the data and records that should contain the UDI information, or reflect UDI information from manufacturing, does not make it all the way through the supply chain to distributors or importers, all the way to the end user,” he said.
5. No UDI Labeling Specifications
Agostino explained that in a number of instances, production documentation, learning device master records, and other documents lacked specifications or requirements for the UDI label.
6. No UDI Process Validation
Another common 483 observation involves not having validated processes during medical device manufacturing. UDI issues in the field have been traced back to lack of process validation.
7. Failure to Maintain Records
“This does touch upon a number of different areas that FDA has actually called out as being problematic in relation to UDI, just from complaint handling to production with device history records, to device master records, inspections, and, ultimately, just document management,” he said.
These seven types of UDI 483 observations are, according to Agostino, “the different areas that have been called up by FDA through the years as being problematic in relation to UDI.”
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