South Carolina Food Safety Consultant

It depends on what you make. Meat and poultry establishments are inspected by Clemson University's Livestock Poultry Health division, which runs the state Meat and Poultry Inspection program under a cooperative agreement with USDA FSIS, or by USDA FSIS directly if you hold a federal grant. Manufactured food, bakeries, beverage plants, and retail food operations are regulated by the South Carolina Department of Public Health. Shellfish harvesting and dealer certification fall under the state shellfish sanitation program operating within the National Shellfish Sanitation Program framework. Facilities shipping interstate also carry FDA obligations. Several facilities answer to more than one of these simultaneously, which is why we map jurisdiction before drafting any documentation.

They are different documents under different regulations, and some facilities need both. A HACCP plan is required for seafood processors under 21 CFR Part 123, juice processors under Part 120, and meat and poultry establishments under 9 CFR 417. A Food Safety Plan under 21 CFR Part 117 is required for most other FDA-registered manufacturing facilities and must be prepared by a Preventive Controls Qualified Individual. A seafood processor that also produces a non-seafood sauce line may need a Part 123 HACCP plan for one product and a Part 117 Food Safety Plan for the other. Determining which applies to each line is part of our initial assessment.

Molluscan shellfish dealers must be certified by the state and listed on the FDA Interstate Certified Shellfish Shippers List to ship across state lines. Certification requires compliance with the National Shellfish Sanitation Program Model Ordinance, which governs facility construction and sanitation, harvest water classification, shellstock tagging and 90-day tag retention, and time-to-temperature controls that tighten during warmer months to control Vibrio parahaemolyticus and Vibrio vulnificus. Dealers must also maintain a Vibrio control plan where applicable. We build these systems and prepare operations for the certification inspection.

For a facility with reasonable existing documentation and a cooperative team, 45 to 90 days from gap assessment to mock audit is a realistic range. Facilities starting close to zero, or those pursuing a first GFSI certification such as SQF or BRCGS, more often need three to six months, largely because certification schemes require evidence that the system has been operating over time. Records of internal audits, management review, and verification activities cannot be manufactured retroactively. If you have a customer deadline, tell us early and we will tell you honestly whether it is achievable.

Respond in writing, and do it promptly. FDA expects a written response within approximately 15 working days of the inspection close if that response is to be considered before the agency decides on further action. A strong response addresses each observation individually with a specific corrective action, a completion date, and supporting evidence such as revised procedures, training records, or verification data. General assurances that the issue has been addressed tend to invite escalation to a Warning Letter. We help draft responses and, more importantly, help implement corrections that survive the follow-up inspection.

Possibly, and it is worth checking early. Products with a finished equilibrium pH of 4.6 or below that have been acidified, and that are packaged in hermetically sealed containers, generally fall under the acidified foods regulation at 21 CFR Part 114. That triggers establishment registration, a scheduled process filed by a recognized process authority, and specific record-keeping. Kombucha, hot sauces, pickled vegetables, and certain cold-brew coffee formulations frequently qualify. Standard beer and distilled spirits do not, but flavored and mixed products can. Getting this determination wrong is one of the more common and more costly oversights among South Carolina craft producers.

The rule applies to foods on the FDA Food Traceability List, and South Carolina's industry is heavily represented on it. Finfish, crustaceans, molluscan shellfish, leafy greens, fresh-cut fruits and vegetables, melons, herbs, cucumbers, tomatoes, peppers, and certain cheeses and eggs all appear. If you manufacture, process, pack, or hold any listed food you must maintain Key Data Elements at defined Critical Tracking Events and produce them to FDA within 24 hours of a request. We map your supply chain against the list, build the record structure, and test it with a mock recall before you need it under pressure.

Yes, and preparation is where most of the value sits. We conduct a documented gap assessment against your chosen scheme and edition, build the missing system elements including food safety culture requirements, root cause analysis, internal audit programs, and management review, then run an unannounced-style mock audit that mirrors how the certification body will actually assess you. Most first-attempt failures stem from system elements that exist on paper but have no operating history behind them, which is a problem best identified months before the auditor arrives rather than during the audit itself.

Regularly. A significant share of our South Carolina work involves specialty food companies scaling out of shared kitchens into their own facilities, small seafood dealers, and family operations adding a processing line. Engagements can be scoped to a single deliverable such as a HACCP plan, a scheduled process determination, a label review, or a pre-inspection readiness check, rather than a full program build. Getting the regulatory basics right while you are small is considerably cheaper than retrofitting a compliance program onto an operation that has already grown.