Inspection, Regulatory Focus News Letter

FDA Provides Flexibility for Start of Routine Inspections on Small Farms

Hi, Welcome to FWQRC Regulatory Focus News Letter

Here we are going to discuss about flexibility for Start of Routine Inspection on small farms

The U.S. Food and Drug Administration is providing flexibility for when states may begin conducting routine inspections of small farms, other than sprouts operations, under the Food Safety Modernization Act (FSMA) Produce Safety Rule.

Routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule, will generally begin in Spring 2020; however, the FDA is clarifying that states receiving competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) may begin routine inspections as early as January 1, 2020. This clarification is being made after several requests from states to have greater flexibility to align routine inspections with the winter growing season where applicable. Individual states will make final decisions on whether to initiate their first routine inspections of small farms at the earlier date in January 2020. States that want to begin routine inspections of small farms, other than sprouts operations, on January 1, 2020, should prioritize completing their planned inspections of large farms subject to the rule before conducting routine inspections of those small farms.

The major compliance date for small farms, other than sprouts operations, subject to the Produce Safety Rule arrived on January 28, 2019; however, FDA had previously announced that routine inspections would not begin until Spring 2020. The delayed start to routine inspection follows a similar delay for the start of routine inspections of large farms (other than sprout operations), both done to provide the FDA and its state partners additional time to conduct education and outreach.

On Farm Readiness Reviews (OFRR), offered in collaboration with the National Association of State Departments of Agriculture (NASDA), will continue to serve as a helpful tool to farmers as they determine how prepared they are to comply with the requirements of the Produce Safety Rule.

Additional information about inspections, the rule and any related resources can be found on the Produce Inspections webpage at FDA.gov.

Thanks for visiting FWQRC blogs……

Contact FWQRC™ for GMP Training, Auditing by QP, eCTD, GAP Analysis, Risk Assessment, CAPA, CSV, Method development/Validation, ADE/PDE Values, Facility & Product Registrations

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s