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Medical device companies that operate in the United States are subject to regular inspections by the FDA to establish their ongoing compliance with 21 CFR Part 820 and other legislation. Following such an inspection, the FDA representative may issue an FDA 483, which lists observations made at your facility that may be a cause for concern when it comes to compliance. Medical device companies need to understand how to read an FDA 483 and what response is required when an inspectional observation form is received following an FDA inspection.
FDA 483 forms are typically filled out by an FDA representative following an inspection of your facility. They can be written on paper, filled and submitted electronically, or created in a PDF and printed. The form is filled by listing observations in order of significance, with the most important items at the top, and the rest following. The most common observations reported on 483 forms are listed below - make sure that these observations cannot apply to your medical device company!
Receiving an FDA 483 at the end of an inspection is not the end of the world, but it is important that medical device companies respond correctly to ensure that the issues are corrected before the noted inspectional observations turn into non-compliance issues. Once the inspector leaves, medical device companies have just 15 days to prepare a written response to the observations listed in the 483.
Ensure that you understand the meaning behind each listed observation by discussing the 483 in detail with the FDA inspector at the time the form is issued. If any observation errors were made by the inspector, it is important that you address and correct them before the inspector leaves.
Beyond that, we've created detailed guidelines for medical device companies responding to 483 observations from the FDA and created FDA 483 response templates to make the process even easier for you.
An FDA 483 form and a warning letter from the FDA are not the same things!
After the initial inspection is completed and the inspector supplies an FDA 483 form to the manufacturer, there are a few steps before a warning letter could be sent. The inspector will complete an Establishment Inspection Report that documents what was observed during the inspection. The report will be reviewed by higher officials in the FDA, and a warning letter could be sent if the review suggests that a serious violation could exist.
Unlike FDA 483s, warning letters will be immediately posted on the FDA website and could negatively impact your business. Therefore, it is important that you respond to FDA 483s as quickly as possible to communicate your intent to fix any issues observed in the inspection and any steps you have already taken to do so.
You can read more about the difference between FDA 483 and Warning Letters here.
The most common observation listed on FDA 483 forms is that procedures are not fully documented, or are not documented at all. Medical device companies that use paper procedures for manufacturing processes run the risk of not being able to produce the materials during an inspection, resulting in an observation and possible violation.
Greenlight Guru's Quality Management Software platform provides a single location where FDA auditors can quickly find and reference all documented procedures for your medical device manufacturing company. Secure cloud-based document storage ensures that once you document a procedure, it remains available for access by all authorized personnel at your organization and for review by FDA auditors.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →