In February 2016, UL’s Linda Chatwin and MasterControl’s Walt Murray presented a live webinar “FDA Just Left! Now What?” to over 250 sites. The following is the list of questions asked during that webinar with responses.
You can view the webinar recording online at : Webinar Recording: FDA Just Left! Now What?
1. Regarding your November 2015 webinar, would we would know about the findings while the FDA inspector(s) is (are) still on-site? Would there be a daily closing meeting? Would there be a final closing meeting with FDA before they leave our premises?
A: The FDA will always conduct a closing meeting at the conclusion of the inspection. They may or may not provide daily recaps, but you should ask
for them. Chances are, you will know how the inspection is going each day, and even if the FDA does not provide a daily recap, you should have
one internally to discuss the day, and how to better prepare for the next day. Also, try to close any gaps that the FDA may note as they inspect before they leave. They will likely still write the nonconformance, but would note that it was corrected while there, if you request it.
2. What recommendations do you have for a company performing packaging activities in the United States but wholly exporting all products? We have not yet been visited but expect to be?
A: If you do not sell any products in the U.S., you should not have an inspection unless the products come back into the U.S. through some other distribution route. If that occurs, then you should prepare for an inspection. If you are contacted for an inspection, you can show that all products are exported and should be able to have the inspection cancelled; again unless the products are re-imported to the U.S.
3. We just received our first 510K approval and have not marketed the product in the U.S. What is the time line for FDA to come in for an inspection after the approval?
A: If the product is going to be marketed in the U.S. then you can expect an inpection any time in the next two years. If the product is considered by FDA to be higher risk than other products, they may inspect sooner, and if they receive complaints or MDRs, they will consider the risk involved with the product for inspection likelihood.
4. What would be the typical duration from the FDA inspection to the date of issue of 483?
A: Typically, 483s are issued at the time that the inspector concludes the inspection and leaves the facility. However, the inspection report is reviewed at the FDA district office, and additional 483s may be issued after such a review. I would expect that within a month of the inspection; however there is no set timeline for this.
5. Does 15 days mean working days Monday to Friday, so 3 weeks in total?
A: Yes, 15 working days would equal 3 calendar weeks in total, unless there were federally recognized holidays involved.
6. How does the FDA define preventive action?
A: Preventive action involves reviewing operations feedback materials to dtermine if steps can be taken that would prevent non-conformances
from occurring, either as a result of implementing a corrective action and reviewing other related processes, or simply analyzing statistical information generated in the company.
7. How does the Form 483 at a Contract Manufacturing Organization (CMO) affect the sponsor? What are the consequences and is there
any action the sponsor can undertake to avoid it?
A: In this question, I presume the sponsor is the company who contracts with a CMO to manufacture product for the company. The sponsor (ompany) needs to monitor the CMO to ensure that they are in conformance with FDA requirements. If 483s are issued, the sponsor (company) needs to do a risk assessment to determine the seriousness of
the finding(s) and whether the CMO is capable of correcting the find(s) timely and successfully, and that the safety and efficacy of the company’s product will not be compromised. If serious enough, the company may need to contract with another CMO.
8. We are a small (30 employees) medical device manufacturer located in Ottawa, Canada. How many inspector(s) should be coming from FDA? How long?
A: There is no way to predict the answer to this question. The FDA performs inspections both to a schedule and on a risk-based approach. If it is a routine inspection, they will usually send one inspector. There is no set time for inspections; the length can directly tie to the health of the
organization being inspected. If everything is in order, perhaps 2-5 days would be sufficient.
9. When is the start of the 15 days countdown for the 483 observation(s)? When the inspector leaves or when we receive the report?
A: The 15 days begins from the time the form 483 is issued, which is typically when the inspector leaves the facility.
10. Can the FDA fine a medical device company before they give a consent decree or are fines given only after a consent decree? And if yes, what type
of non-conformance would make the FDA move forward? What are the typical costs of these various fines? Everyone talks about “fines” however no one actually provides dollar values. This would be helpful in some cases when performing the risk.
A: There are a number of ways that fines and penalties can be imposed. There is no dollar value given because the amounts assessed are tied to
the level of non-conformance and type of nonconformance. If a company has a specific area that they are wanting to perform a risk assessment on,
that company should analyze the FDA policy for that area and determine the potential fines, and factor that into their assessment.