Service area
FDA & FSMA Compliance
Preventive controls, inspection readiness and FSVP built to withstand scrutiny.
- Service lines
- 13 listed
- Delivery
- Onsite and remote
- Coverage
- United States
Overview
What this covers
Most FDA-registered facilities are not cited because they lack good intentions. They are cited because a hazard analysis was never reconciled with what the plant actually does, because monitoring records have gaps nobody reviewed, or because the person named as PCQI has never been walked through what the role requires during an inspection.
SURU Compliance works inside the operation. We read your process flow, your labels, your supplier files and your existing records, then close the distance between the written food safety plan and the daily practice. Where a requirement may not apply to your products or operations, we say so rather than selling you a program you do not need.
Who this is for
- Human food facilities required to register with FDA under section 415 of the FD&C Act
- Manufacturers, processors, packers and holders subject to preventive controls under 21 CFR Part 117 Subpart C
- Importers acting as the FSVP importer for one or more foreign suppliers
- Operations that have received an FDA Form 483, a Warning Letter, or an inspection observation and need a credible written response
- Companies approaching an initial FDA inspection, a new product category, or a first co-manufacturing agreement
FDA & FSMA Compliance services
- FSMA compliance
- FDA inspection preparation
- FDA response assistance
- Preventive Controls
- PCQI support
- FSVP development and compliance
- Supplier verification
- Foreign supplier compliance
- FDA records preparation
- Recall assistance
- Traceability compliance
- Food facility registration assistance
- Regulatory gap assessments
Engagements are scoped to what applies to your operation. Where a listed service is not relevant to your products, processes or jurisdiction, we will say so.
How an engagement runs
Sequenced so each step earns the next.
Nothing gets written before the operation is verified, and nothing is declared complete before it has been tested against the standard it will be judged by.
Regulatory gap assessment
We map your operation against the rules that plausibly apply — preventive controls, FSVP, traceability, registration, labeling touchpoints — and produce a prioritised finding list separating genuine regulatory exposure from best-practice improvement.
Hazard analysis and plan development
Process flow verification, hazard identification across biological, chemical (including radiological), and physical hazards, and preventive control determination with documented justification for controls you did and did not apply.
Records and monitoring build-out
Monitoring, corrective action, verification and validation records designed so a reviewer can follow a lot from receiving to shipment. Records that cannot be reconstructed under questioning are the most common failure point we find.
Inspection readiness and response
Mock inspection walkthroughs, document staging, front-desk and floor-team preparation, and — where an inspection has already happened — structured assistance drafting a response with root cause analysis and evidence of correction.
Regulatory basis
The requirements behind the work.
Applicability depends on your products, processes, size and jurisdiction. Exemptions and modified requirements exist throughout these rules, and part of the engagement is establishing which apply to you.
Summaries below are educational and simplified. They are not legal advice and do not replace the text of the regulation or guidance from your regulatory authority or counsel.
- 21 CFR Part 117
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Subpart B covers CGMPs; Subpart C covers the food safety plan. Qualified facility and other modified requirements may apply depending on your size and sales.
- 21 CFR Part 1 Subpart L
- Foreign Supplier Verification Programs. Applies to the importer of record's FSVP obligations, including hazard analysis, supplier evaluation and verification activities, where an exemption does not apply.
- 21 CFR Part 1 Subpart S (FSMA 204)
- Additional traceability records for foods on the Food Traceability List. Compliance timing has been the subject of FDA rulemaking activity; we work from the current published requirements and confirm applicability to your specific products.
- 21 CFR Part 1 Subpart H
- Food facility registration and renewal, including the biennial renewal window and U.S. agent requirements for foreign facilities.
- 21 CFR Part 7 Subpart C
- Recall procedures and FDA-requested recall policy, alongside the Reportable Food Registry obligations that may be triggered by a responsible party.
Applied by industry
How this looks in practice.
The same regulatory framework produces very different programs depending on the operation it lands in.
- Food ManufacturersFDA 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.
- ImportersAs the FSVP importer you answer for hazards created in facilities you do not control. FSVP inspections are records inspections — and the file has to be producible on request.
- Private Label BrandsYour name is on the package and someone else's plant made it. Oversight of the co-manufacturer is the whole job, and a certificate on file is not oversight.
- StartupsDecisions made in the first six months — formulation, process, co-packer, label — set your compliance cost for years. Most of them are cheaper to get right than to fix.
- Small Food BusinessesSmall operations are not exempt from everything, and they are rarely exempt from what they assume. We identify what genuinely applies and build the smallest program that satisfies it.
Questions we get asked
FDA & FSMA Compliance — common questions
Do we need a PCQI on staff, or can SURU be our PCQI?
Part 117 requires that certain activities be performed or overseen by a preventive controls qualified individual. That individual can be an employee or a qualified third party, but in practice a facility benefits from having internal capability rather than depending entirely on an outside consultant. We commonly serve as PCQI support — developing and reviewing the plan, validating controls and coaching your named individual — and we will tell you plainly when your situation calls for training an internal PCQI instead.
We just received an FDA Form 483. What happens first?
We start by reading the observations against the underlying regulatory citation and your actual records, because a response that restates the observation without evidence of root cause and correction rarely closes the loop. Depending on the severity and on your counsel's position, our role is typically to assist with the technical content of the response, the corrective action plan, and the verification evidence. We are not a law firm; where an observation carries legal or enforcement exposure we recommend qualified counsel be involved.
Does FSMA 204 traceability apply to us?
It depends on whether you manufacture, process, pack or hold a food on the Food Traceability List, and on whether an exemption applies to your operation. Many companies find that only a subset of their products is in scope. We assess product by product rather than assuming the whole facility is covered, and we build the key data element and critical tracking event records only where they are actually required — plus whatever your customers contractually demand beyond that.
Can you guarantee we pass an FDA inspection?
No. No consultant can, and any firm that promises it is worth walking away from. Inspection outcomes rest with the investigator and the agency. What we can do is make sure your food safety plan matches your operation, your records are complete and retrievable, your team knows how to host an inspection professionally, and known deficiencies are corrected before an investigator finds them.
Related
Other practice areas
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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.
Read moreDietary Supplements
Part 111 is a specification-driven rule. Most observations we see trace back to a specification that was never established, an identity test that was never performed, or a batch record that a quality unit signed without the supporting data attached.
Read moreManufacturing
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.
Read more
FDA & FSMA Compliance
Tell us what you need to be ready for.
Send the operation, the products and the deadline. We will tell you which parts of fda & fsma compliance apply to you and what it takes to be ready — in writing, before you commit.
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.