The FDA has been increasingly aggressive about inspecting medical device companies over the past several years, and for start-up companies who have already gone through the painstaking process of securing venture capital, submitting a 510(k) application and beginning the manufacturing process, an FDA inspection could be the green light that moves your product into the marketplace or an obstacle that brings your operations to a halt.
The FDA publishes a publicly available manual called the QSIT - Quality System Inspection Technique - that guides FDA inspectors in conducting the inspection of your facility. Medical device manufacturers who wish to do well on an upcoming FDA inspection would be wise to familiarize themselves with QSIT, the most common deficiencies found in FDA inspections, and the relevant guidelines for medical device quality systems found in 21 CFR Part 820.
When your company is visited by an inspector from the FDA, they will use the guidelines in QSIT to perform the inspection. You can access the complete QSIT guide here. Here are some of the main points that will be addressed within the inspection, along with some other information from the guide:
Each year, the FDA inspects thousands of medical device manufacturers for compliance with 21 CFR Part 820 and other legally mandated requirements. When the agency observes instances of non-compliance, it issues a Form 483 describing the issues that manufacturers must respond to and address in order to pass a subsequent inspection. The most common deficiencies found and reported during FDA inspections on Form 483 are:
When the FDA issues a 483, medical device manufacturers have a very limited time to adequately respond and correct the issue, otherwise, they could face a shipping hold on their products and huge revenue losses, not to mention the cost of getting the quality system up to date.
Greenlight Guru's quality management software (QMS) can help you organize your quality system and streamline FDA inspections, saving you time and money in the process. With Greenlight Guru's cloud-based QMS, your documents are securely stored in the cloud where they can be electronically accessed by an FDA inspector. Document and version controls help ensure that your quality documents are all up-to-date and accessible when you need them, and a paperless QMS ensures that nothing is inconveniently missing on the day of your inspection.
As a result, your QMS can be inspected by the FDA in significantly less time, and you'll avoid the inconvenience and expense of fighting the FDA over their Form 483 observations or worse, a warning letter.