FDA 21 CFR Part 117 — the Preventive Controls for Human Food rule, the heart of FSMA — scopes how Tampa Bay specialty food manufacturers monitor and document cooling. The cooling step is almost always a process preventive control. Here is what FDA expects from the record.
21 CFR 117 applies to facilities required to register with FDA under Section 415 of the Food, Drug, and Cosmetic Act. Most specialty food manufacturers in Florida — sauce, dressing, condiment, beverage, baked-good commissary, packaged seafood — are covered. Exemptions exist for very small businesses (under $1M annual sales averaged over three years) and for facilities solely under USDA FSIS jurisdiction.
Florida-licensed manufacturers under FDACS still answer to FDA at the federal level for food covered by 21 CFR 117.
The Food Safety Plan must identify cooling as a preventive control where time-temperature management protects against pathogen growth. Cooked TCS food, batch-tank cool-down, blast-chill steps — all typical CCPs. The plan documents the parameters, the monitoring procedure, the corrective action procedure, and the verification procedure.
FDA wants to see the plan signed by the Preventive Controls Qualified Individual (PCQI).
Cooked TCS food: from 135°F to 70°F within 2 hours, then from 70°F to 41°F within 4 additional hours. From FDA Food Code §3-501.14, adopted by reference into the PCHF preventive controls regime. Six hours total, with the first two being the hardest.
Some specific products have alternative cooling procedures validated by the PCQI. Document the validation.
FDA wants time-temperature records that prove the cooling curve. The frequency must be sufficient to demonstrate compliance. Continuous monitoring (60-second intervals) is the practical standard now; manual hourly checks are still acceptable but require disciplined execution.
Records must include who took the reading, when, what equipment was used, and what the reading was. ColdSentry™ and ArcticOS™ provide this in auditable form.
When monitoring detects a deviation — cool-down running long, sensor showing out-of-spec — the corrective action procedure activates. The procedure must address what to do with affected product (re-condition, divert, dispose), what to do with the equipment (repair, recommission), and how to prevent recurrence.
Corrective action records are part of the lot file.
Verification confirms the preventive control is actually working. Calibration of monitoring equipment, review of records by a different qualified person, and product testing where appropriate. Calibration of cooling-step probes is typically quarterly with documented procedure.
FDA records review during inspection looks at verification first — it is the fastest way to assess plan integrity.
Reanalysis is required at minimum every three years and whenever something changes — new equipment, new product, new ingredient supplier, new evidence of a hazard. Cooling equipment changes (new blast chiller, retrofit refrigerant) trigger reanalysis of the cooling preventive control.
Document the reanalysis decision and the result.
Specialty food manufacturers across Hillsborough, Pinellas, and Pasco counties are inspected on a risk-based schedule. ColdSentry™ continuous monitoring at 60-second intervals provides the evidence FDA wants. ArcticOS™ centralizes cooling records, calibration logs, corrective action records, and verification activities for inspection-day retrieval.
FrostIQ™ does not apply here — it is built for DBPR-licensed foodservice. Manufacturing is FDA-regulated.
FSMA is the Food Safety Modernization Act of 2011. 21 CFR 117 is one of several regulations promulgated under FSMA. PCHF is a major part of FSMA implementation.
Every covered facility must have a PCQI — someone who has completed the FSPCA-approved curriculum or has equivalent qualifications. Small manufacturers often outsource the PCQI role.
From 135°F (cooked) to 70°F in 2 hours, then 70°F to 41°F in 4 more hours. Six hours total.
The rule requires monitoring frequency sufficient to demonstrate compliance. Continuous monitoring is the practical standard for any meaningful production volume; manual checks are acceptable but require discipline.
Food Safety Plan, monitoring records, corrective action records, verification records, calibration records, and a sample of lot files. ArcticOS™ centralizes all of these.
Suncoast Cold Systems handles process refrigeration and cooling for specialty food manufacturers across Tampa, St. Petersburg, Clearwater, Brandon, Riverview, Temple Terrace, and Wesley Chapel. 24/7 dispatch. Licensed Class A A/C Contractor (FL #CAC1824642), EPA 608 Universal, OSHA 30 Construction.
The traceability companion rule under FSMA.
State licensing for Florida food manufacturers.
PM that protects PCHF compliance.