If the company is placing Medical Devices on the US market, the FDA may carry out an establishment inspection in order to verify the processes compliance as established in the 21 CFR 820. What does this compliance involve for the company?

 The US market is certainly one of the most attractive in the world in terms of commercial opportunities and profitability. However, this involves several pre and post-market requirements compliance established by local Regulatory Authorities for companies that intends to sell their Medical Devices in the local area. Among post-market requirements, there is also the possibility that the FDA (Food&Drug Administration) visit those establishments involved in products manufacturing and marketing, in order to verify the processes compliance with what established by the Federal Code, in particular the 21 CFR 820. This part of the Code sets out the Good Manufacturing Practice requirements to whom the above-mentioned subjects must demonstrate compliance. But what does this mean for the inspected company?

The inspection organization

Once the company received the inspection notification from the FDA, it is necessary to collaborate in order to logistically organize the visit. This notification arrives about two or three months before the planned period and the inspection lasts four days. It is important to know that, in terms of costs, the visit is totally covered by the FDA and no external cost is required for the inspected company. However, there are many organizational aspects that must be tackled: starting from supporting the search of a hotel for the investigator to the preparation and possible translation of the preliminary documentation needed.


The company Quality System adjustment

Unfortunately, involved companies may not always know that they are required to meet the 21 CFR 820 regulatory requirements or that this involves different actions in comparison with keeping the system compliance with ISO 13485:2016 o 9001 standards. Processes, establishments, records must be modified or corrected from the very first moment, once the first establishment registration is carried out, and it must become a part of the routine business flows . This important aspect must be  mainly taken in charge by the Top Management. In fact, a few months are not enough to permanently and properly adjust the Quality System to the FDA audit.  Moreover, there are some peculiar aspects of the Code relating to infrastructures and working environment that cannot be considered “last minute”.


The inspection management

The FDA inspection lasts four days: generally, the investigator approach of is top-down, unless it is a For Cause or Follow up inspection. This means that from the first day the specific aspects analysis and cross-records are more and more detailed, in order to check the system adequacy. Managing an FDA inspection is no easy task, including psychological aspects, because the investigator is a federal official and the approach is extremely detailed.


Follow up

If the inspection is completed with the issuance of a Form 483, including the most important observations, the company may choose – and it is recommended – to answer within 15 working days. In this case the company shall: collect all necessary records, provide the modified documentation and report the corrective actions to be taken following the investigator’s reports. In case of serious shortcomings and non-conformities to 21 CFR 820 requirements during the inspection, the investigator may issue a Warning Letter or even interrupt the ongoing inspection.



Organizing and managing an FDA inspection should not be underestimated. First of all, it is important that the company knows the requirements established by the Federal Code and immediately starts to meet them, avoiding a last minute implementation. Furthermore, it is important that the Top management and the internal staff are aware of the importance and the commitment of this inspection, that might involve not only additional documentation, but also structural changes to the establishment.



Have you read “USA: wake up… FDA is speaking!” and “How to effectively implement the Unified Device Identification (UDI) FDA program”?

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Marisa Testa
QA/RA Manager