Industry
Compliance for Food Manufacturers
FDA inspection, customer audits and GFSI certification all test the same underlying system. We build it once, properly, so each of those reviews draws on the same evidence.
- Risks mapped
- 5 primary risks
- Regulatory references
- 5 cited
- Structure
- Risk → Regulation → Solution
Context
Where food manufacturers get caught out
A manufacturing facility is typically answering to three audiences at once: FDA under the preventive controls rule, retail and foodservice customers with their own supplier requirements, and a GFSI-benchmarked certification body. Companies that build separate programs for each end up maintaining three sets of records and failing all three.
We build one coherent system. A hazard analysis that reflects the plant as it runs today, preventive controls with validated critical limits, prerequisite programs that support them, and verification records that answer whichever audience asks.
01 — Risk
What actually goes wrong.
Ranked by consequence rather than by how visible or convenient the fix is. Relative exposure levels below are SURU's professional assessment of typical operations in this segment — not a regulatory classification, and not a rating of your specific business.
Environmental pathogens in RTE production
Critical exposureReady-to-eat product with no kill step downstream of exposure carries the highest consequence profile in the industry. Harbourage sites in equipment, drains and wet floors are the recurring source.
Undeclared allergens
Critical exposureUndeclared allergens are consistently among the leading causes of FDA-regulated food recalls, and the root cause is usually a label control or changeover failure rather than an ingredient error.
Hazard analysis drifting from the actual process
High exposureNew equipment, a new supplier, a rework loop or a line-speed change alters the hazard picture. Plans that are only reassessed annually are frequently describing last year's plant.
Supplier-controlled hazards without verification
High exposureWhere a hazard is controlled before receipt, the supply-chain program has to prove it. Relying on a certificate of analysis with no defined program is a common and consequential gap.
CAPA that closes findings without fixing causes
Moderate exposureRepeat findings across audit cycles are usually a root cause analysis problem, not a compliance-effort problem, and they compound into downgraded audit ratings.
02 — Regulation
What the rules typically require.
These are the frameworks that most often apply to this kind of operation. Exemptions, modified requirements and jurisdictional differences are common, so applicability has to be confirmed against your specific products and operations.
Educational summaries only. Not legal advice, and not a substitute for the regulation text, your regulatory authority's guidance, or qualified counsel.
- 21 CFR Part 117
- CGMP and preventive controls for human food, covering the hazard analysis, process, allergen, sanitation and supply-chain preventive controls, verification, and the recall plan. Modified requirements may apply to qualified facilities.
- 21 CFR Part 121
- Intentional adulteration mitigation strategies and food defense planning for covered facilities, with exemptions including many small businesses.
- 21 CFR Part 113 / Part 114
- Thermally processed low-acid canned foods and acidified foods, each with scheduled process, process authority and filing requirements that operate independently of Part 117.
- 21 CFR Part 101 and FALCPA
- Labeling, nutrition and allergen declaration requirements, including sesame as a major food allergen. Label control is a food safety control, not only a marketing function.
- 21 CFR Part 1 Subpart S (FSMA 204)
- Traceability records for listed foods, including transformation and shipping records. Applicability is determined food by food.
03 — SURU solution
What we do about it.
Scoped to your operation, sequenced so each step earns the next, and delivered with the documentation you will need when someone asks you to prove it.
Food safety plan built from a verified process flow
We walk the line before we write, confirm the flow diagram against reality, and document the reasoning behind every preventive control decision — including the hazards you decided not to control at a CCP and why.
Prerequisite program build-out
Sanitation with validated contact times, environmental monitoring designed around zone mapping and harbourage points, allergen changeover validation, and food defense where applicable.
Supply-chain program
Supplier approval criteria, verification activity matched to hazard severity, and documented review — so a supplier-controlled hazard is genuinely controlled and not merely assumed.
GFSI readiness and internal audit capability
Clause-level gap assessment against SQF, BRCGS, FSSC 22000 or IFS, internal auditor training, and a pre-assessment audit under audit conditions. Certification decisions rest with the certification body.
FDA inspection readiness
Mock inspections, document staging, and preparation for the specific questions investigators tend to open with — plus structured assistance if a Form 483 response is already needed.
We do not promise inspection outcomes, audit scores, certification results or regulatory findings. Those decisions rest with regulators, certification bodies and auditors.
04 — Services
The practice areas this draws on.
- Service
FDA & FSMA Compliance
The FDA Food Safety Modernization Act moved the regulatory burden from reacting to contamination to proving you prevented it. We build the hazard analysis, preventive controls, supplier verification and records systems that carry that burden — and we prepare your team for the inspection that tests them.
View service area - Service
Manufacturing
Preventive controls only work when the programs beneath them do. We build and audit the prerequisite layer — sanitation, environmental monitoring, allergen segregation, food defense, supplier approval — and the CAPA discipline that keeps findings from repeating.
View service area - Service
GFSI & Certification
Retail customers increasingly require a GFSI-benchmarked certification, and the first audit is where unprepared systems get expensive. We run readiness assessments, build the documentation, train internal auditors and conduct pre-assessment audits against the exact issue of the standard you will be audited to.
View service area - Service
HACCP
A HACCP plan is only worth what its critical limits can be defended with. We develop, rebuild and independently review plans across seafood, juice, retail and specialized processes — including the variance and validation documentation that regulators ask for first.
View service area
Also serving
Other industries
05 — Food Manufacturers
Talk to us about your food manufacturers operation.
Tell us what you run, where you run it, and what is coming — a re-inspection, a customer audit, a first import, a certification deadline. We will tell you what applies and what it takes to be ready.
Direct contact
- info@surucompliance.com
- 651-329-4787
- Serving food businesses nationwide, onsite and remotely.
SURU Compliance is a regulatory consulting practice. We are not a government agency, a certification body, or a law firm, and we do not provide legal advice or guarantee regulatory outcomes.