Now Available – New FDA Guidance for Small Business Size

Posted On June 24, 2019— Written By and last updated by

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.