FDA to Resume Routine Inspections

— Written By and last updated by Rhea Hebert
en Español / em Português

El inglés es el idioma de control de esta página. En la medida en que haya algún conflicto entre la traducción al inglés y la traducción, el inglés prevalece.

Al hacer clic en el enlace de traducción se activa un servicio de traducción gratuito para convertir la página al español. Al igual que con cualquier traducción por Internet, la conversión no es sensible al contexto y puede que no traduzca el texto en su significado original. NC State Extension no garantiza la exactitud del texto traducido. Por favor, tenga en cuenta que algunas aplicaciones y/o servicios pueden no funcionar como se espera cuando se traducen.


Inglês é o idioma de controle desta página. Na medida que haja algum conflito entre o texto original em Inglês e a tradução, o Inglês prevalece.

Ao clicar no link de tradução, um serviço gratuito de tradução será ativado para converter a página para o Português. Como em qualquer tradução pela internet, a conversão não é sensivel ao contexto e pode não ocorrer a tradução para o significado orginal. O serviço de Extensão da Carolina do Norte (NC State Extension) não garante a exatidão do texto traduzido. Por favor, observe que algumas funções ou serviços podem não funcionar como esperado após a tradução.


English is the controlling language of this page. To the extent there is any conflict between the English text and the translation, English controls.

Clicking on the translation link activates a free translation service to convert the page to Spanish. As with any Internet translation, the conversion is not context-sensitive and may not translate the text to its original meaning. NC State Extension does not guarantee the accuracy of the translated text. Please note that some applications and/or services may not function as expected when translated.

Collapse ▲

Blue and white graphic with text Update: Routine Inspections to Resume

Late last week, the U.S. Food and Drug Administration (FDA) published Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system. With this statement, the FDA announced plans to move forward with routine inspections later this month (July 20).

The FDA paused routine on-site inspections in the U.S. in March 2020 in response to the COVID-19 pandemic. Inspectors continued for-cause inspections deemed mission critical by using tools such as remote assessments and import alerts.

The FDA will use a COVID-19 Advisory Rating System to assess the number of COVID-19 cases in areas based on state and national data. This system will be shared with state regulators.

The system uses three (3) metrics to set the FDA’s agenda: the phase of the state, statistics at the county level and intensity of infection. Based on this data, the FDA will determine the most appropriate types of regulatory activities.

The three (3) types of inspections that could occur in a state or area based on the results of the COVID-19 Advisory Rating System are

  1. mission critical inspections only,
  2. all inspections with ways to help protect staff who have self-identified as being in a vulnerable population or
  3. all regulatory activities.

Another important announcement explains that domestic inspections will be pre-announced for the foreseeable future to FDA-regulated businesses.

A good business practice is for facilities to have a robust visitor policy. Businesses should also communicate the details of this policy to investigators as inspections are announced.

Review our fact sheet to learn about ways your facility can use CGMP to reduce the spread of COVID-19.

Food Safety Modernization Act Current Good Manufacturing Practices for Food for Animals and COVID-19
How existing facility Standard Operating Procedures (SOPs) on personal hygiene and sanitation can be adapted to mitigate the spread of COVID-19

Need help preparing for inspections? Review our newest factsheet with tips to help you prepare.

How Animal Food Facilities Can Prepare for Regulatory Inspections
Though they can be a source of worry, the fact of the matter is that many animal food facilities often think about preparing for inspections as the inspectors walk through their doors. One of the reasons for this is because the “what if” questions can be large in number, and so facilities get frustrated with trying to come up with a plan. With this in mind, we asked some regulators what advice they have for facilities in order to be proactive and help make the process go more smoothly. This document presents a number of practices that are not required, but might be useful as facilities prepare for, are subjected to, and evaluate the results of inspections.

If you have questions about FDA inspections, please contact Marissa Herchler.