See me, smell me: FDA advises on interactive remote drug facility assessments during COVID-19 | Arnall Golden Gregory LLP


Channel the Who’s Tommy The soundtrack and classic song “See Me, Feel Me,” the Food and Drug Administration released a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Biological Research Monitoring Facilities During COVID-19 public health emergency. ”1 Covered facilities are those that manufacture pharmaceutical and biological products, those covered by the agency’s biological research monitoring program, and outsourcing facilities registered under Section 503B of the Federal Food Act, drugs and cosmetics.

This bulletin highlights some of the key points outlined in the guidance.

  • A facility is not required to accept the FDA’s request to conduct a remote facility assessment. He can refuse the request. However, the agency notes that the decision may, as a result, delay its ability to assess the company’s facility or product, which may affect a timely regulatory decision on other matters, such as review and approval of the application.
  • The FDA will decide whether or not to conduct a remote interactive assessment. He will not take requests from companies. The agency will make its decision, in part, based on the company’s compliance history and product and facility risks. Once the FDA has determined that a remote interactive assessment is appropriate for a particular facility, the agency will notify the facility and the requester by email or phone.
  • Prior to conducting a remote interactive assessment, the FDA will host a virtual meeting to discuss logistics, responsibilities, and expectations. During this brief meeting, the agency can discuss several topics, including, but not limited to, the objectives and scope of the remote interactive assessment, the timing of the virtual interactions and the expected duration of the l remote interactive assessment, FDA’s expectations during the facility’s live broadcast process, and technological limitations that could “interfere with or prevent” the facility’s assessment by the FDA.
  • During a remote assessment, the FDA expects companies to cooperate with the same level of transparency as they would during an in-person inspection by the FDA. The agency may: request document review, use live broadcast and / or pre-recorded video to review a facility, assess a facility’s corrective actions, and provide verbal updates to the facility on observations and outstanding issues. The FDA will not issue an FDA Form 482 (Notice of Inspection) to announce or initiate a remote interactive review.
  • The FDA plans to request and review the documents prior to a remote interactive assessment to ensure live interactions are as effective as possible. However, additional documents may be requested during the actual assessment. The agency expects that all documents requested during the meeting will be provided in electronic form or be accessible by screen sharing during a live interaction.
  • At the end of the inspection, the FDA will hold a closing meeting with the facility management to discuss any observations. The agency will submit a list of observations, but will not issue an FDA Form 483 (Inspection Observations). A remote interactive assessment is do not considered as a final action of the agency. However, like an on-line and in-person inspection, the FDA expects establishments to respond to observations during discussion and / or provide responses, in writing, to observations within 15 business days to United States.
  • FDA will provide a copy of the Remote Interactive Assessment Final Report to the facility. This report and any written list of observations May be subject to disclosure under the Freedom of Information Act.
  • If the agency decides that a live, in-person inspection will be required as a result of the Remote Interactive Assessment, they will use the information obtained from the Remote Interactive Assessment to prepare for and perform the inspection.

AGG observations

  • Since the FDA’s decision to schedule a remote interactive assessment depends, in part, on facility / product risk and compliance history, it is unclear whether the agency will use this tool to evaluate a new or new technology or manufacturing site.
  • Because an interactive remote assessment is do not considered an official inspection, the FDA notes that after issuing a warning letter, holding a regulatory meeting, or following enforcement action, the agency will continue its practice consisting of performing an in-person inspection to confirm that any corrective actions have been implemented.
  • It is not known how participating in a remote interactive assessment will benefit a business if the business does not have the capacity to fully participate (that is to say, lacks the ability to virtually involve the appropriate personnel, provide required documentation, lack of IT capabilities) because the FDA will expect the same level of compliance as a live, in-person inspection.
  • While most businesses have upgraded their IT capabilities as a result of the pandemic, it is very important that any IT issues are identified and resolved. before any scheduled meeting with the FDA to ensure a smooth process during virtual tours.
[1] Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid

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