• >
• Compliance
• >
• Inspection in practice: what should you know?

Inspection in practice: what should you know?

It is not uncommon for companies to be subject to different types of inspections and controls, each with its own set of regulations and procedures. Such inspections may be conducted by various authorities – State Institute for Drugs Control (available in Czech https://www.sukl.cz/farmaceuticky-prumysl/kontrolni-cinnost), inspection of work, GDPR reviews of the Data Protection Authority or dawn raids of the Competition Authority (UOHS) – available in Czech https://uohs.gov.cz/cs/pristup-k-dopravni-infrastrukture/vyrocni-zpravy-a-kontrolni-cinnost.html. To avoid potential risks and stressful situations that may arise as a result of lack of knowledge of the rights and obligations of inspectors or even the inspected company, we have prepared a short summary.

The State Labor Inspection Office is entitled to inspect employers’ compliance with labor law regulations, while the State Institute for Drugs Control supervises in the areas of good manufacturing, laboratory and clinical practice, transfusion service facilities and human tissues and cells. Whether the inspection is initiated by a complaint or by an actual finding in the course of the inspection body’s normal activities, the inspection body may carry out preliminary actions to assess the necessity and scope of the inspection before it starts.

The inspection is initiated by presenting the inspector’s authorization (the inspected subject has the unconditional right to request that the authorization be presented if the inspector has not done so himself), followed by the delivery of the inspection notice. Inspectors are entitled, in particular, to demand access to the premises of the inspected entity and to require proof of the identity of the persons present, to question employees, to inspect internal documents and systems, to make copies thereof, etc.

Upon the end of the inspection, the inspectors shall draw up their findings in a report with which the inspected entity shall have the right to be notified. In the event of irregularities found, the inspection bodies shall be entitled to propose or order measures to remedy such irregularities. You may appeal the protocol in case you do not agree with the findings. This is very important because protocol may serve as a base for future sanctions.

Going through the inspection process can be stressful, but it does not necessarily cause you to panic. Being prepared, in terms of knowing the rights you can exercise during an inspection, and cooperating fully with inspectors can help mitigate risks and ensure a trouble-free inspection. This can be achieved, for example, through preventive trainings or internal guidelines that provide a brief and comprehensible description of the steps involved, including the roles that each staff member should play during the inspection. Do not forget that every inspection must follow the law, professional legal support of interna lor external lawyer is crucial.

Our team is ready to help you in controls and inspections, offering advice and support in every step of the way.

Mgr. Igor Pieš partner

igor@kastnerpies.cz