FDA Guidance Details Examples of Foreign Inspection Refusals That Lead to Inadmissibility
FDA issued a guidance document Oct. 20 on the types of actions the agency will consider refusal of inspection by foreign food facilities and governments for the purposes of refusing food imports from those facilities. Under federal food safety laws, food from foreign facilities must be refused admission to the U.S. if the facility does not cooperate with FDA inspectors.
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The guidance document details examples of when FDA may refuse admission to articles from a facility where the foreign facility or government did not allow FDA to schedule an inspection, or when the foreign facility or government did not allow FDA to conduct an unfettered inspection.
For example, FDA will consider a lack of response within 24 hours to an FDA inspection scheduling request to be a refusal of an inspection, with the 24 hours running from proof of delivery. FDAl also wil consider it a refusal of inspection if a facility agrees to an inspection start date then requests a later date without giving a reasonable explanation.
Examples of a facility not allowing FDA to inspect a facility include a refusal to permit entry into an establishment (including by not answering phone calls when an inspector arrives), closing a facility on the day of inspection and sending staff home on the day of inspection. Other examples include closing off a part of the facility, limiting the inspection to an unreasonably short period of time or causing unreasonable delays or refusing to allow collection of evidence or access to records.
The guidance also details examples of ways government can refuse inspection for inadmissibility purposes. That can happen in many of the ways facilities can be deemed to refuse an inspection, as well as by not permitting FDA inspectors to enter the country, directing the inspectors to leave the country or not allowing inspectors to inspect a particular type of facility.
FDA said that inspectors will inform facilities refusing inspection of the consequences of continuing refusal before the agency considers the refusal final and lists the facility on import alert 99-32.