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Questions Related to FDA Inspection

By Linda Chatwin

  • Published 18.12.15
Time To Read 1 minute

In November 2015, Linda Chatwin, RAC Esq. of UL and Walt Murray, Quality & Regulatory Professional of MasterControl, co-presented a live webinar “FDA Just Called! Now What?” The webinar was attended by over 350 people and the following represents over 20 questions asked during the webinar Q&A session.

You can view the webinar recording at this link.

  1. Have you thought about the effects of an FDA audit on distributors as well? Would it be the same process or similar process in general as manufacturers? Domestic distributors who do not import devices are not required to register their facility, or to list devices with FDA. Accordingly, they would not be subject to FDA inspections. If a distributor is the initial importer of a device, they are required to register their facility, but not list devices. Since they would have a facility registration, they may become subject to an FDA inspection of their complaint handling, MDR reporting, corrections and removals, labeling and other records requirements. Keep in mind this would be on a risk-based approach, so if the product is not high risk, or FDA has no pressing issues that have come to their attention, they are not likely to inspect distributors.
  2. What is typical for the lag time between the FDA calling and appearing at your doorstep? Per Linda Chatwin RAC, in her experience it varies, depending on FDA schedule, 1-3 weeks. If FDA is inspecting because of a serious issue (“for cause” audit) with the specific product, or in the product area, the manufacturer could be inspected at any time, with or without advance notice. Note, drug inspections still may be unannounced.
  3. How often does the FDA typically perform an on-site inspection? There is no real correct answer to how often. It really depends on the risk factors that FDA applies to the products.
  4. Do you have the right to turn an auditor away if the correct staff is unavailable for an unscheduled visit? You can advise the FDA Inspector that certain people aren’t available; however, FDA can continue without them. There is an expectation that adequate back up is in place in the organization.
  5. Can we insist that the audit is performed during normal business hours? You can ask. FDA’s instructions are to conduct inspections during reasonable business hours. If it is “For Cause” inspection, that may be change, and particularly if product is going to be confiscated and it is produced on several shifts. We advise to state “These are our hours of operation” in the initial presentation at the opening meeting, so that FDA is aware of normal business hours.

Please complete the form to download the full Q&A which includes answers to 23 questions asked live during the webinar.