The article provides an overview of the factors resulting in delaying or refusing an inspection.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance dedicated to the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Once finalized, the document will provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
Regulatory Background
The current regulatory framework requires the authority to define the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection by the virtue of a respective guidance document to be issued. Under the FDA Reauthorization Act, the above requirement applies to the aspects related to medical devices. As further stated in the guidance, a drug or device is “deemed to be adulterated” if the owner, operator, or agent of the factory, warehouse, or establishment at which the drug or device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection or refuses to permit entry or inspection of such factory, warehouse, or establishment. The authority also mentions that the present guidance is intended to replace a similar document issued by the FDA earlier in 2014. At the same time, the said guidance remains effective till the present one will be finalized. The current version of the document is a draft issued solely for the purpose of public consultations – the authority encourages industry representatives to provide their feedback and suggestions to be considered when developing the final version of recommendations.
The present document outlines the scope of behaviors the authority will consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry of inspection. At the same time, it is explicitly stated that the list of examples provided in the document is non-exhaustive, so the decision will be taken on a case-by-case basis. Moreover, the authority mentions that the four main behaviors referred to in the document are not mutually exclusive since in real-world scenarios a few of them could take place simultaneously. The document also applies the term “facility” to any establishment, warehouse, or similar object that could be covered by the scope of an inspection under the applicable legislation.
In accordance with the Food, Drug, and Cosmetic (FD&C) Act, the authority is entitled to carry out an inspection in a way appropriate to the matters to be assessed. The act employs the word “reasonable”, even though it is not specially defined in the regulations, however, it empowers the authority to determine what is reasonably necessary in each particular case. As further explained in the guidance, FDA intends to work with facilities to conduct inspections and procure the information necessary to achieve the objective of the inspection; FDA will consider reasonable explanations for behavior that may otherwise be considered to be delaying, denying, limiting, or refusing an inspection.
Inspection-Related Rights: Key Points
The applicable legislation entitles the authority, represented by its designed officers, to enter the premises and conduct inspections in accordance with the respective regulations and in a reasonable manner. According to the definition provided, an inspection conducted by the authority stands for a careful, critical, official examination of a facility to determine its compliance with the laws and regulations administered by the FDA. Moreover, the authority is also entitled to request additional information and documentation to be provided before the inspection. During the inspection itself, the representatives of the authority should be allowed to access the documents related to the subject matter of the inspection and make copies thereof. Facilities that are subject to inspection in accordance with the applicable regulations are obliged to complete the appropriate registration, and also to provide certain information to the authority. The latter additionally emphasizes the importance of keeping the contact information up-to-date in order to ensure efficient communication on matters related to inspections, and also to notify the authority about any changes thereto without undue delay.
In accordance with the current regulatory framework, a refusal to permit entry or inspection, or access to records and making copies thereof constitutes a prohibited act. As it is stated in Section 501(j) of the FD&C Act, a drug or medical device will be deemed adulterated in the case it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
In summary, the present draft guidance issued by the FDA outlines the scope of acts or omissions that, when committed by a party responsible for a medical device, could result in a violation of the applicable regulations on inspections. The document provides an overview of the corresponding requirements and highlights specific aspects to be taken into consideration in this respect.
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