Tradeshow Season is Upon Us
If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem. These inspections are supposed to happen at least once every two years. There is no requirement, though, for the FDA to give you prior notice of their intent to visit your facility.
When an investigator does show up, they are required to present you with an FDA form 482 (Notice of Inspection) along with their credentials. Upon their arrival, the appropriate person(s) within your company should be immediately contacted (quality assurance manager, production manager, area director, etc), and the inspector should be accompanied by at least one of these people at all times.
The inspector will typically want to evaluate your production process, review specific related records, interview employees and collect samples. For example, they may want to know who performed different aspects of production, how authority is delegated, how and where data is recorded, how staff has been trained, whether or not product was manufactured in compliance with procedures and whether record retention requirements are upheld. The investigator is not allowed to ask for access to personnel data, other than training records. Financial statements, sales data, pricing information and research records are also not to be shared with inspectors.
To prepare for an FDA visit, it is suggested to read the FDA document “Investigations Operations Manual (IOM)”. This guidance document was created for the FDA inspectors to follow. Generally, the inspector is looking to verify that your company is following cGMP, your staff is familiar with regulations and that there is documentation available to provide proof of compliance regarding training and monitoring. The FDA will also audit any process validation protocols, along with data and information related to the 510(k) registered device(s).
Upon conclusion of their inspection, the investigator will need to meet with your management team to discuss any significant findings and concerns. A written report will be given to the management team, which will include a summary of any objectionable conditions (also known as a form 483).
Let’s talk monitoring!
Talk with one of our experts to get your questions answered and see how we can help you solve your continuous monitoring pain points.
Related posts
