The new article addresses the aspects related to different grounds for delays occurring before and during an inspection.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Once finalized, the document will describe the authority’s position with respect to actions or omissions of medical device manufacturers and other parties involved in operations with medical devices impacting the inspections conducted by the authority in the course of its surveillance activities. It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed in order to ensure compliance thereto. Moreover, an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to delays of inspections and potential reasons thereof. First of all, the authority acknowledges that some of these reasons are beyond the reasonable control of an entity subject to inspection, however, will expect a proper justification to be provided with respect to the behavior considered to be impacting adversely the course of an inspection and resulting in additional delays. The authority also mentions that where an owner, operator, or agent causes the unreasonable delay of an inspection, this may cause the drugs or devices manufactured, processed, packed, or held therein to be adulterated under section 501(j) of the FD&C Act. The document further describes different types of delays that could take place and highlights the key points associated thereto.
Delay Scheduling Pre-announced Inspections
Under the general rule, for-cause and routine surveillance inspections related to drugs do not require to be pre-announced. However, the authority usually tends to contact facilities subject to inspection in advance in order to facilitate the inspection process. On the contrary, existing legislation requires the authority to pre-announce inspections involving foreign and domestic facilities conducting operations with medical devices, except the for-cause inspections. In situations when the pre-announcement is not required under the applicable regulations, the authority will decide on the way of action to be followed on a case-by-case basis. The said pre-announcement could be in a form of a phone call or sending an email. In case of a foreign site involved, the authority will take into account the local factors, such as holidays or weather conditions, when scheduling an inspection.
The authority further provides examples of behaviors considered to be causing delays, namely:
- A facility will not agree to an announced inspection start date and does not give a reasonable explanation for its failure to do so;
- After scheduling an inspection, a facility requests a later start date without giving a reasonable explanation;
- A facility fails to respond following FDA’s attempts to contact the facility’s designated contact(s).
The above actions and omissions could result in the medical device in question being considered adulterated.
At the same time, in case the manufacturer requests an inspection to be rescheduled and provides a reasonable justification, the authority can accept it.
Delay During an Inspection
The document also covers the aspects related to delays that could take place in the course of the inspection itself. In accordance with the applicable regulations, the authority has broad authority in order to be able to assess compliance with the respective regulatory requirements the facility in question is subject to. Thus, any actions or omissions impacting the possibility of the authority’s investigator to conduct an inspection in a proper way will be considered as delaying the inspection. At the same time, the authority acknowledges that the mere presence of its representatives could result in minor confusion and slightly impact normal operations of the facility during the inspection, so in case the good faith efforts would result in minor delays, they would not be considered unreasonable.
According to the guidance, examples of the delays include, inter alia, the following ones:
- A facility does not allow the FDA investigator access to an area of the facility until a specific future date or time even though the area is operational and is an area of the inspection site that the FDA has the authority to inspect, without giving a reasonable explanation;
- A facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection;
- A facility agrees to the pre-announced inspection date, but when the investigator enters the facility, the necessary facility personnel are not available, or the firm’s management informs the investigator that operations are shutdown, without providing a reasonable explanation.
At the same time, the authority will have no objections to preventing FDA investigators’ access to a specific area before the appropriate measures or precautions are duly taken.
Delay Producing Records
According to the guidance, it is vitally important for the authority to be able to review and collect copies of the appropriate records related to drugs or medical devices in question. For instance, in the course of an inspection, the FDA investigator may review the device-related documentation to assess compliance with the respective regulatory requirements. The authority acknowledges that the facility will require reasonable time to produce copies of such records, however, this process should not be unreasonably delayed. As explained by the authority, the examples of undue delays include the following ones:
- During an inspection, the FDA investigator requests, within a reasonable timeframe, records that FDA has authority to inspect, but the facility fails to produce the requested records within the timeframe requested by FDA, without reasonable explanation;
- FDA requests records pursuant to section 704(a)(4) or 704(e) of the FD&X Act, but the facility fails to produce the requested records in a timely manner, without reasonable explanation.
The above situations could result in the medical device in question being considered adulterated.
In summary, the present FDA guidance describes potential issues that could result in delays at different stages of the inspection process. The document also explains the approach to be applied by the authority when determining whether these delays are reasonable.
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