Stakeholders want clarity from FDA on circumstances for delaying or limiting inspections
The Advanced Medical Technology Association (AdvaMed) and ophthalmology product maker Alcon urged the US Food and Drug Administration (FDA) to allow manufacturers more latitude in being able to delay or limit inspections before deeming products adulterated. They also urged FDA to clarify what constitutes a reasonable explanation for delaying, denying or refusing an inspection.These comments were in response to FDA’s revised draft guidance issued in December 2022 on circumstances for delaying, denying or limiting an inspection. (RELATED: FDA guidance proposes devices be deemed adulterated for refusing inspections Regulatory Focus, 19 December 2022)
Under current FDA guidance, only drugs can be adulterated if FDA inspectors are barred the door. The draft guidance aligns with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices to be deemed adulterated and refused entry for firms that block FDA inspections.
The deadline for comment closed on 14 February.
AdvaMed took issue with language in the draft which stated that “if a facility fails to respond following FDA’s attempts to contact the facility’s designated contact in scheduling a pre-announced inspections that may cause drugs or devices to be adulterated.”
The group suggested the text be modified to state that device should be deemed adulterated if “a facility fails to respond following FDA’s multiple attempts to contact the facility’s designated contact without reasonable explanation.”
The group also asked for additional examples of reasonable explanations for allowing scheduling delays. For example, firms should be able to deny inspections based on the fact they may be “hosting multiple audits at the same time means that the facility staff will have competing obligations.”
AdvaMed also said it wanted more clarity on examples of delays during an inspection which would result in the device being deemed adulterated. The guidance states that an example of a delay is when “a facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individual for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection.”
AdvaMed suggested that “unreasonable amount of time” be changed to “a prolonged period of time.”
Addition of language on data privacy
Stakeholders also suggested that industry should be given more latitude in being able to limit photography during inspections.
The guidance states that manufacturers can ban photography if products are sensitive and photographs would have an adverse effect on drug quality, or if a manufacturer can document that taking pictures would affect the raw materials and adversely impact product quality.
AdvaMed asked for additional text stating that manufacturers have the right to refuse investigators from taking photographs if this compromises the privacy of employee or if it poses a safety risk to employees.
Alcon concurred, saying that FDA should add text stating that “FDA will take into consideration data privacy laws with respect to photographs.”
More leeway for data deletion
Alcon also suggested that firms should be able to delete “unnecessary columns or rows of data not pertinent to the inspectors’ request” without the deletion being considered an act of adulteration.
The draft guidance considers the following an example of limiting access to records: a facility “maintains electronic records but omits or limits the data contained in the electronic records when providing electronic copies of the records to FDA. This includes but is not limited to actions such as removing data columns in Excel, removing data columns in Excel, removing data from the electronic record when providing the record to FDA, exporting data into reports without including all of the data fields (unless otherwise requested by FDA), or locking the electronic worksheet so that the data cannot be searched, sorted, or analyzed by FDA.”
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