FDA Acidified Foods Compliance (21 CFR Part 114)
The FDA Acidified Foods Compliance add-on helps food businesses that produce acidified foods — hot sauces, salsas, pickles, relishes, and other products with an equilibrium pH ≤ 4.6 — meet their obligations under 21 CFR Part 114.
When active, a Compliance section appears in the left navigation with four screens: Scheduled Processes, CCP Log, Deviations, and Inspection Packet.
Who needs this
Once your business crosses the FDA's annual sales threshold ($1M for most categories), every acidified food product must have a scheduled process reviewed by a credentialed Process Authority. Each production batch must log pH and temperature readings at Critical Control Points (CCPs), and any batch that falls outside the approved process must be documented as a deviation. All records must be kept for three years and be available to an FDA inspector within 24 hours.
Iraca already captures lot numbers and production runs — this add-on adds the compliance layer on top of that existing data.
Scheduled Processes
A scheduled process is the FDA-approved production method for a specific product. It defines the target pH ceiling, minimum fill temperature, the Process Authority who reviewed it, and the expiration date for the next review.
To add a scheduled process:
- Go to Compliance → Scheduled Processes and click New Process.
- Select the product, enter the process name, Process Authority name and contact, approval date, and review due date.
- Enter the target pH (e.g.,
4.00) and target fill temperature in °F (e.g.,185.00). - Optionally upload the Process Authority letter PDF.
- Click Save.
Status badges:
- Active — process is current and within its review period.
- Pending review — the review due date is within 60 days. An email reminder goes to all admins at 60 days and again at 14 days.
- Expired — review due date has passed; the process is flagged as non-compliant.
Document upload — you can attach the Process Authority letter PDF to each record. The file is stored securely in Backblaze B2. The document appears as a downloadable link on the process detail card.
CCP Log
The CCP Log screen is a tablet-optimized production floor view designed for use with gloved hands on a shared tablet.
To log a CCP reading:
- Go to Compliance → CCP Log.
- Select the active production run from the list of runs started today.
- Tap Log pH or Log Temperature, enter the measured value, and tap Submit.
- Iraca immediately checks the value against the scheduled process targets for that product:
- Green checkmark — reading is within spec.
- Red alert — reading is out of spec. You'll be prompted to report a deviation.
CCP readings are stored with the logged-by user, the timestamp, the measured value, and whether the reading was within spec.
Deviations
A deviation records that a production batch fell outside its approved scheduled process — for example, a pH reading above the target ceiling or a fill temperature that dropped too low.
To report a deviation:
- Go to Compliance → Deviations and click Report Deviation, or tap Report Deviation from the out-of-spec prompt on the CCP Log screen.
- Select the production run and lot (if applicable), choose the deviation type, and describe what happened.
- Enter the corrective action taken.
- Set the disposition:
- Destroyed — product was discarded.
- Reworked — product was reprocessed.
- Released with justification — product was released with documented rationale.
- Under review — disposition is pending.
Resolving a deviation — once the corrective action is complete, open the deviation record and click Resolve. Enter the final corrective action and disposition, then save.
Filtering — the Deviations table can be filtered by date range, open/resolved status, and disposition.
Missing Process Gate
When a production run is started for a product that has no active scheduled process, Iraca's behavior depends on your compliance setting in Settings → Compliance:
- Warn (default) — the run proceeds and a dismissable warning banner appears.
- Block — the run is rejected. Only owners and admins can override this by temporarily switching to Warn mode.
To change this setting, go to Settings → Compliance (owner or admin only).
Inspection Packet
The Inspection Packet is a print-ready PDF formatted for an FDA inspector. It covers a date range you specify and includes:
- Cover page — tenant name, date range, generated timestamp.
- Scheduled processes — one entry per product, including Process Authority details and a note referencing the attached original PA letter.
- Production log — every run in the date range with lot number, product, quantity, and date.
- CCP readings — all pH and temperature readings, with out-of-spec values flagged in red.
- Deviations — full deviation records including corrective actions and dispositions.
- Lot traceability index — a cross-reference of lots to sales orders.
To generate a packet:
- Go to Compliance → Inspection Packet.
- Choose a date range.
- Review the checklist — Iraca shows a count of what will be included and warns if any products in the date range have no scheduled process on file.
- Click Generate Packet to download the PDF.
Note: The inspection packet references PA letter filenames in the body. Attach the original PA letter PDFs to the physical packet before providing it to an inspector.
Availability
The FDA Acidified Foods Compliance add-on is available on Pro and Canopy plans. Activate it in Billing → Add-ons.