BEWARE – FDA Inspections in China with 5 day notice

mdi recently received an email from one of our clients in China that read:

“We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday.

Is this normal to be contacted from the embassy and on such short notice as it is out of character for all our previous inspections? Normally, we are given suggested dates and it is on an official letterhead. Normally, you are also informed as our USA Agent

Could you please advice on this.”

 

This was a first. It appears the FDA is using their local Chinese-stationed investigators to conduct the inspections while relying on the same inspection notification method as used in the USA, namely a 3-5 day pre-notice for medical device inspections. This is a lot different than what the foreign medical device manufacturers have gotten used to, a three month pre-notice of an upcoming inspection.

It appears that this audit is being conducted by an FDA investigator who is stationed locally. (FDA has stationed FDA investigators locally in several foreign countries to conduct their inspections saving travel time and travel costs).

Getting a 3-5 days pre-inspection notice is what is typically done in the USA for medical device companies. The fact that foreign companies were previously given a 90 day notice was a real advantage for these companies so that they could sufficiently prepare for an upcoming inspection.

The shorter pre-inspection notice for foreign companies appears to be a pretty new development and will put a lot of pressure on a company’s management and quality staff to be prepared for the upcoming inspection.

With this short notice, it also makes it difficult to have a consultant from the USA arrive on site for assistance with the FDA audit which is something we usually recommend for our foreign client companies.

Asking the FDA to postpone the inspection is not a good idea unless the company is going to be closed during the week that FDA plans to visit. Trying to refuse the inspection can be considered a “Refusal for the Inspection” and could lead to the FDA issuing a warning letter and stopping shipments at the US borders called detention without physical examination (DWPE). To get this automatic detention lifted would require an FDA inspection of your operations.  This scheduling could take some time.

However, if your operations are closed, the FDA cannot audit and they would postpone the inspection. Keep in mind such notice of the company closure has to be given to the FDA at the time of their inspection notification.

The best way to be prepared for dealing with this FDA’s new inspectional  approach for foreign companies is to have a mock FDA QSIT audit conducted on site at least once a year to understand the most up to date FDA policies for conducting inspections. If you do run into this inspectional situation, having someone available to understand the FDA’s audit findings and how to interpret the 483, List of Observations, is critical. Having a well-crafted response submitted in the correct time frame could be critical to avoiding the issuance of a warning letter that could result in DWPE of future shipments. It is very important to have someone take detailed notes on how the investigator is conducting the inspection and what records were reviewed and what questions were asked and how they were answered.

 

 

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form. Reference “FDA Inspection Policy”.