The COVID 19 pandemic continues to change the way business is conducted and procedures are followed. Even government agencies such as the FDA has had to adapt their systems when travel restrictions have interfered. Will these alternate methods of conducting inspections cause a permanent shift and will quality assurance/control measures remain up to previous standards?
FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the Agency Cannot Inspect a Facility Due to Factors Including Travel Restrictions
FDA is providing additional information to drug manufacturers on circumstances under which the agency plans to approve an application, issue a complete response (CR) letter, or defer action when a site cannot be inspected due to factors including travel restrictions related to the public health emergency, and how FDA plans to prioritize inspections as travel restrictions are lifted.
While the number of inspections that can be conducted by FDA during the COVID-19 public health emergency are limited due to travel restrictions, FDA intends to continue using alternative tools, when appropriate, to evaluate facilities. Decisions regarding applications will be based on the totality of the information available to FDA, including information obtained from use of the alternative tools, which may include remote interactive evaluations as described in FDA’s recent guidance to industry. Based on an assessment of the product information provided in the application and based on available information about the facility or site, and as further explained in the revised guidance, FDA will take one of the following actions:
For further information, please contact CDER-OPQ-Inquiries@fda.hhs.gov.
FDA will continue to review comments submitted to the docket for this guidance. This information, plus information on how FDA will prioritize inspections and additional clarifications, has been included in the revised guidance, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,” and posted to FDA’s web page, Manufacturing, Supply Chain, and Drug Inspections – COVID-19.
mdi will continue to monitor the FDA alternative methods to inspect companies and determine if this new matrix is having an effect on consumer safety. For more information on this FDA policy please contact mdi at: firstname.lastname@example.org and ref: FDA alternate inspections