Now Available – New FDA Guidance for Small Business Size

Posted On June 24, 2019— Written By and last updated by Rhea Hebert
en Español

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.

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 announcement of a new FDA guidance document

The Food and Drug Administration has released a new guidance document for determining the number of employees for purposes of the “small business” definition in parts 117 and 507 (CGMP and Preventive Controls for Human and Animal Food).

Calculating the number of full-time equivalent employees (FTE) is important in determining whether or not a business is considered a “small business” for Food Safety Modernization Act (FSMA) compliance.

The document contains several example facilities and situations, as well as formulas, to calculate these FTEs. These examples may be helpful for facilities that are affiliates or subsidiaries of another company or facility. The calculation for the number of FTEs at a company is not limited to just those working at the facility.

If you have any questions regarding the Preventive Controls for Animal Food rule, please contact Marissa Herchler.

Download the full guidance document.