{"product_id":"u-s-low-acid-canned-foods-management-system-21-cfr-113-108-35","title":"U.S. Low-Acid Canned Foods Management System (21 CFR 113 \u0026 108.35)","description":"\u003cp\u003e\u003cem\u003eAn editable documentation system for U.S. plants that make thermally processed low-acid foods in hermetically sealed containers, built around 21 CFR Part 113 and the registration and process filing rules of 21 CFR 108.35.\u003c\/em\u003e\u003c\/p\u003e\n\u003ch2\u003eOverview\u003c\/h2\u003e\n\u003cp\u003eA low-acid canned food is safe only if its scheduled process is right and is followed every time. Is the product really low-acid? Is the establishment registered and the process filed? Who is the process authority, and what happens when a retort deviates? This system puts the answers in writing.\u003c\/p\u003e\n\u003cp\u003eIt starts with classification, separating low-acid canned foods from acidified, acid, refrigerated and frozen products, then assesses how Part 113, Part 108 and 21 CFR Part 117 apply, with the 21 CFR 117.5(d) exemption explained. The documents do not set scheduled processes or supply thermal values. Those come from your process authority, and the system records them.\u003c\/p\u003e\n\u003cp\u003eThe files reference 21 CFR Part 113 and 21 CFR 108.35 as shown on the eCFR at the end of August 2026. Binding text is kept apart from FDA guidance, and HACCP is a voluntary layer. AGS is independent and is not affiliated with the FDA or USDA FSIS. Regulations are referenced by citation, and no regulation text is included.\u003c\/p\u003e\n\u003ch2\u003eWhat this system covers\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eClassification and applicability:\u003c\/strong\u003e a product classification decision framework, Part 113 and Part 108 applicability, and a Part 117 applicability assessment.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcess authority and scheduled processes:\u003c\/strong\u003e process authority engagement, scheduled process control, critical factors, formula control, and heat distribution and heat penetration study records.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThermal processing:\u003c\/strong\u003e commercial sterility and C. botulinum control, retort operations, and the rule that retort operators work under a person trained at an FDA-recognised school.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eContainer integrity and cooling:\u003c\/strong\u003e double seam, glass and retort pouch procedures, a defect classification programme, and cooling and cooling-water control.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration and filing:\u003c\/strong\u003e records for establishment registration and process filing on Forms FDA 2541, 2541d, 2541f and 2541g.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeviations and release:\u003c\/strong\u003e deviation handling under 21 CFR 113.89, hold and release, traceability, and recall under 21 CFR 108.35(f).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSupporting programmes:\u003c\/strong\u003e sanitation, water, suppliers, allergens, food defence and fraud, calibration, maintenance and change.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eModels, training and assurance:\u003c\/strong\u003e illustrative HACCP product models, training modules, forms, checklists, an Excel workbook of registers and logs, internal audit, inspection readiness, gap assessment and a 30-day roadmap.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eWho it's for\u003c\/h2\u003e\n\u003cp\u003eFacilities that manufacture, process, package or hold thermally processed low-acid foods in hermetically sealed containers for the U.S. market: canned vegetables, beans, soups, sauces, ready meals, and retort pouch and tray products. It suits plants that work with a process authority. The canned meat and poultry models flag possible USDA FSIS rules, and the canned seafood model adds 21 CFR Part 123.\u003c\/p\u003e\n\u003cp\u003eFor a Codex-style HACCP system for the same product family, see the HACCP Canned \u0026amp; Retort Foods Management System. Acidified products are out of scope here and are covered by the U.S. Acidified Foods Management System (21 CFR 114).\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":57395107299668,"sku":"AGS-16-033","price":890.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/AGS-16-033.png?v=1790973560","url":"https:\/\/agskits.com\/products\/u-s-low-acid-canned-foods-management-system-21-cfr-113-108-35","provider":"Apex Global Solutions","version":"1.0","type":"link"}