FDA-TRACK: FDARA Section 902 Inspections Dashboards

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Section 902 of the FDA Reauthorization Act (FDARA) requires FDA to publish annual reports on inspections of facilities necessary for approval of a drug or a device conducted during the previous fiscal year (the Report). The FDARA Section 902 Inspections Dashboards (FDARA 902 Dashboards) provide a concise, interactive, and visual presentation of data presented in the Report. Data are provided in the Dashboards below for FY 2024. The FDARA 902 Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data.

The FDA organizations providing information for the FDARA 902 Dashboards are the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Inspections and Investigations (OII).

Report Elements

The same Report Elements that apply to the Report also apply to the FDARA 902 Dashboards. The Report and FDARA 902 Dashboards contain data on inspections necessary for the approval of specified human drugs and medical devices. FDA notes the following regarding specific report elements:

With respect to drug-related inspections, section 902 is limited by its terms to information related to inspections of facilities necessary for approval of drugs under section 505 of the FD&C Act. Biological products, including biosimilars, licensed under section 351 of the Public Health Service Act, are not included in this report.
Section 902 is limited by its terms to information related to inspections of facilities, which we view as referring to facilities subject to inspection under section 704(a)(1) of the FD&C Act
Section 902 refers to information related to inspections of facilities necessary for approval of a drug. FDA views this provision as generally requiring information not only with respect to approval of original new drug applications or abbreviated new drug applications but also with respect to approval of supplements to such applications, including both prior approval supplements and changes being effected supplements.
With respect to device-related inspections, section 902 is limited by its terms to information related to inspections of facilities necessary for approval of a device under section 515 of the FD&C Act.^[1] Because humanitarian device exemptions are granted under section 520(m), information concerning humanitarian use devices is not included in this report. FDA views section 902 as requiring information not only with respect to approval of a premarket approval application, but also with respect to approval of supplements to such applications.
FDA views section 902(1) (A), (B), and (C) to only be relevant to drug products and not devices.
Section 902 as amended by FDORA 3617 uses the term “report pursuant to section 704(b).” FDA interprets this phrase to refer to FDA Form 483,^[2] Inspectional Observations, which is the list of observations made by FDA investigators during an inspection that is left with the management of the inspected facility at the conclusion of the inspection. With the exception of the data reported in Tables 1 and 6 below, inspections not resulting in issuance of an FDA Form 483 are excluded from the analysis below.
Section 902(1) refers to requests from staff of the FDA “reviewing an application or report.” FDA understands this statutory provision to refer to staff at the reviewing Center at FDA
FDA conducts different types of inspections of facilities in which a conclusion of lack of compliance may result in delay of approval of an application. FDA conducts so-called “pre-approval inspections,” but it also conducts inspections for other purposes, such as routine surveillance and for-cause inspections. Because a pre-approval inspection is requested by staff reviewing an application, FDA interprets section 902(1) to apply to pre-approval inspections.
The result of a pre-approval inspection may be a decision that an application may not be approved. The result of a routine surveillance or for cause inspection may be a WL, issuance of an IA^[3], or the holding of a Regulatory Meeting. For that reason, FDA understands sections 902(2) and (3) to apply to inspections other than pre-approval inspections. However, because section 902 requires FDA to provide information related to inspections of facilities necessary for approval of a drug or for approval of a device, FDA reports information under sections 902(2) and (3) concerning facilities that are referenced in a pending application. FDA understands section 902(4) to apply to both pre-approval inspections and other types of inspections.
We note that by its terms all of section 902 is limited to information related to inspections “that were conducted during the previous fiscal year.” Thus, information reported with respect to section 902(2) does not include data concerning inspections that were conducted during fiscal years prior to FY 2024 that resulted in WLs, IAs, or Regulatory Meetings during FY 2024.
FDA understands section 902(3) to apply, consistent with its terms, to inspections resulting in a WL, Issuance of an IA, or the holding of a Regulatory Meeting. We note that there are, at least theoretically, situations in which a surveillance inspection would lead directly to a more serious enforcement action, such as a seizure, injunction, or prosecution, without a WL, IA, or Regulatory Meeting. Such rare circumstances, if they exist, would not be included. We also note that conditions considered resolved during FY 2024 were typically identified during inspections conducted during prior fiscal years.
FDA understands that section 902(4) refers to the number of facilities that had objectionable conditions observed during an FDA inspection that were conveyed to facility management through an FDA Form 483 issued at the close of the inspection but for which the facility failed to implement adequate corrective or preventive actions, resulting in a withhold recommendation for an application under review.
FDA understands section 902(1)(A), relating to drugs described in section 505(j)(11)(A)(i) of the FD&C Act (21 U.S.C. 355(j)(11)(A)(i), to mean drugs subject to Original ANDAs—
- for which there are not more than 3 approved drug products (including the RLD) listed in the active section of the Orange Book, and for which there are no blocking patents and/or exclusivities at the time the original ANDA was submitted by the applicant; and
- that met the requirements for priority review under section 505(j)(11)(B).
FDA understands section 902(1)(B), relating to drugs for which a notification was submitted in accordance with section 506C(a) of the FD&C Act (21 U.S.C. 356c(a)) during the previous fiscal year to mean drugs, as defined in section 506C(a), for which we are notified by the manufacturer of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States. Data reported for this metric pertains to those drugs where the notification was submitted before the inspection was requested by staff at the reviewing Center at FDA.
FDA understands section 902(1)(C), relating to drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C.356e), to mean drugs that are listed in the drug shortages database as current shortages on the FDA website. Data reported for this metric pertains to those drugs that were placed on the Drug Shortage list before the inspection was requested by staff at the reviewing Center at FDA.

[1] We note that the above-noted FDORA amendments removed reference to “clearance of a device under section 510(k)” from FDARA section 902. Moreover, clearance of a device under section 510(k) of the FD&C Act does not require a pre-clearance inspection and clearance is generally not withheld or delayed based on FDA Form 483 observations. Therefore, information regarding clearance of a device under section 510(k) of the Act will not be shown in the tables below.

[2] More information about FDA Form 483 can be found at: www.fda.gov/ICECI/Inspections/ucm256377.htm

[3] FDA interprets “issuance of an import alert” in FDARA section 902(2) to mean those actions by FDA to place firms or products on import alert.

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