FDA Issues Draft Guidance on Qualified Facilities within the Preventive Controls Rule

As part of the Preventive Controls Rule, FDA establishes 'Qualified Facilities' as those facilities exempt from having to establish HACCP based systems (Preventive Controls), but only having to comply with GMPs. But in order to become 'Qualified', they must submit a form to FDA attesting to their status as 'Qualified". This guidance provides detail on how to submit the required form, Form FDA 3942.

‘Qualified Facility’’ as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or.
• Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

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