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December 1, 2018 Safety and Compliance

Simplified Sample Procedures Available for Food Gases – Qualified Facilities

The new Food Safety Modernization Act and 21 CFR 117 allow for easier and modified compliance if your company can claim “Qualified Facility” status. There are two ways to claim Qualified Facility status. The most common way to meet the Qualified Facility definition is if your entire company sells under $1,000,000 per year of food gases. The modified requirements reduce the burden for Hazard Analysis and Risk-based Preventive Controls (HARPC) and for the Supply-chain Program.

If you wish to claim “Qualified Facility” status and take advantage of these modified compliance requirements, you must submit an “Attestation” to the FDA by 17 December 2018 and every even-numbered year following 2018. The attestation is an easy-to-complete form that can be submitted electronically or through the mail to the FDA.

Additional details about the attestation are available to GAWDA distributors (guidance, PowerPoint, video and attestation forms). If you would like these materials, check out the “Food and Beverage Gas Compliance” Dropbox under the “Qualified Facility – Attestations” folder.

In addition, we have just completed a simplified set of sample SOPs for “Qualified Facilities.” The sample procedures are also posted to the “Food and Beverage Gas Compliance” Dropbox. If you need access to this Dropbox or would like these materials sent directly to you, please contact tom@asteriskllc.com. Also, contact Tom if you would like assistance in electronically submitting the attestation.

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