FDA & USDA Compliance to Pass Your Next Inspection
We’ve assisted 100+ companies like yours to become compliant with the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) regulations by writing your food safety compliance program, training you to implement it, and staying with you until you pass your inspection.
Get Results-Driven FDA & USDA Consulting with a family-run team who knows food safety cover to cover.
What To Expect During Your FDA & USDA FSIS Consultation
During your FDA / USDA consultation, you’ll learn what the requirements are for getting in compliance, how long it takes, and how our process works to assure you pass your upcoming inspection.
Let us evaluate your Food Safety or Management System certification program using our proven process and support you to keep your business moving forward. We will generate actions, activities, and documents to assure you pass your next audit or inspection.
How Can We Assist You With Your Safety Compliance?
FDA and USDA Food safety compliance allows our clients to reduce business risk and grow their businesses by meeting required government food law.
COMMON FOOD SAFETY REGULATORY COMPLIANCE QUESTIONS
+ What Is The Difference Between Food Safety Compliance Vs. Food Safety Certification?
Food safety law is designed to protect the safety of consumers. Food businesses must do their part by following food law in order to meet food safety compliance standards and ensure the safety of their products . Food safety compliance is mandatory, whereas, food safety certification is a voluntary process that many food industry businesses choose to pursue to improve the performance of their company, to stay competitive, to sell to larger customers and to uphold high safety and quality standards of their products.
+ What Are Key Elements Of Food Safety Compliance?
Key elements of food safety compliance include: Hazard Analysis, Risk Assessments, Preventive Controls, Critical Control Points (CCPs), Defined critical limits, Monitoring procedures, Corrective Actions, Identified Verification Procedures, setting up documentation and record-keeping processes.
GlobalSTD will write your food safety compliance programs and we will train you to implement it to pass your next inspection.
+ What Is FDA Food Safety Compliance?
In the United States, the Food and Drug Administration (FDA) regulates: “human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation”. The FDA regulates food items in the U.S., except for meat and poultry products, which are regulated by the U.S. Department of Agriculture (USDA).
The FDA conducts periodic inspections and food facilities should be prepared for an inspection at any time. There are also compliance regulations related to importing food products into the U.S. called the Foreign Supplier Verification Program (FSVP).
GlobalSTD has written over 650+ FDA / USDA food safety programs that comply with government standards and we stay with our clients until you pass. No matter what.
+ What Is USDA Compliance?
USDA compliance is enforced by the Food Safety and Inspection Service (FSIS).
FSIS is an agency of the USDA and it is responsible for ensuring the safety of the United States supply of meat and poultry products. FSIS conducts continuous inspections of meat and poultry processing.
Our Food Safety Regulation Compliance Services:
+ Sanitation Standard Operating Procedures
We will develop your SSOPs and work alongside you to implement them.
+ Environmental Monitoring Programs
We will develop your program, work alongside you to implement it, and train you to keep it running.
+ Supplier Approval Programs
We will develop your supplier approval program, work alongside you to implement it, and train you to keep it running.
+ Food Safety Gap Assessment
Determine gaps in your existing program and facility operations you need to implement in order to pass your inspection and be compliant.
+ Development of FDA or USDA Food Safety Program
We’ll develop your HACCP Plan, FDA Preventive Controls/FSMA Food Safety Plan, Good Manufacturing Practices, Quality Program, Sanitation Standard Operating Procedures, Recall Plan, Allergen Program, Supplier Approval Program, Food Defense Plan and Food Fraud Prevention Program.
+ Development of HACCP Plan
We will develop your HACCP Plan, work alongside you to implement it and support you until it is approved.
+ Startup Businesses
We help businesses to launch its first food safety program.
+ Training
Become an in-house expert at running your program for passing your inspection and creating sustained success.
+ Implement Food Safety Programs
We will work alongside you to implement your HACCP Plan, food safety program, sanitation standard operating procedures and FSVP, making sure you understand how to run the program and how to pass your next inspection.
Since 2021, our FSVP Consultants have assisted many clients throughout the food supply chain and we’ve seen it all. To be compliant with the Foreign Supplier Verification Program (FSVP), you need to have a documented FSVP program.
We develop and implement your FSVP program, train you, and assure you pass your next inspection.
During your FSVP consultation, you’ll learn what the requirements are for being in compliance with FDA, how long it takes, and how our process works to assure you pass your inspection on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
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The Food Safety Modernization Act (FSMA) became law in 2011 and is enforced by the Food and Drug Administration (FDA) to protect public health by focusing on prevention of foodborne illness.
FSMA regulations apply to food businesses both domestic and foreign with some small exceptions. Rules that apply to FSMA, include the Preventive Controls rules for Human and Animal Food, the Produce Safety rule, and the Foreign Supplier Verification Programs (FSVP) rule.
There have been many additions to the FSMA regulations, so be sure to check the FDA’s website for the most up-to-date rules.
Preventive Controls
Food Defense Plan
Food Fraud Plan
Operational and Food Safety Training Program
Good Manufacturing Practice (GMP) Program
Food Safety Plan (Process controls)
Food allergen controls
Sanitation controls
Supply-chain controls
Recall plan
The FDA requires businesses that manufacture and handle human food and animal food to employ at least one individual who is PCQI certified. In order to become PCQI certified, an individual must complete a Food Safety Preventive Controls Alliance (FSPCA) accredited PCQI training course.
The PCQI certified individual is responsible for the implementation and maintenance of food safety plans. Kellerman Consulting provides services to write and implement your food safety plans and training for you to implement them.
Since 2021, our FSMS Consultants have assisted many clients throughout the food supply chain and we’ve seen it all. To be compliant with the FDA’s Food Safety Modernization Act (FSMA), you need to have a documented FSMA program.
To be compliant with FDA’s Food Safety Modernization Act (FSMA), you need to have a documented food safety program. We have written FSMA programs in compliance with FDA requirements for every type of food production and food processing for human food and animal food.
We develop and implement your program, provide training, and assure you pass your next regulatory inspection.
During your FSMA consultation, you’ll learn what the requirements are for being in compliance with FDA, how long it takes, and how our process works to assure you pass your inspection on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your food safety program, you employees will receive a professional and specific training log.
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Since 2017, our food safety consultants have assisted hundreds of clients throughout the Costco supply chain to get certified. Costco updated many of their food safety certification requirements effective April 1, 2023 and changed the name of their audit from Costco GMP to Costco Food Safety Audit.
Costco’s food safety & quality audit expectations have changed. All Costco food safety audits are moving to unannounced except:
Small supplier audits will still be announced.
If a Global Food Safety Initiative (GFSI) recognized scheme including BRCGS, FSSC 22000 etc… requires an announced certification audit.
Our results-driven team will write and implement your Costco food safety audit program using the up-to-date Costco requirements, train you and stay with you until you pass your Costco food safety audit. After completing our consulting process you will be prepared for an unannounced audit.
Ace your Costco Food Safety Audit with a family-run team who knows food safety cover to cover.
During your Costco food safety audit consultation, you’ll learn what the requirements are for getting certified, how long it takes, and how our process works to assure you pass your Costco food safety certification audit on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your Costco Food Safety Audit, you employees will receive a professional and specific training log.
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Since 2017, our Costco Non-foods GMP consultants have assisted hundreds of clients throughout the supply chain with their ISO Management System. Ace your Costco Non-foods GMP audit with a family-run team who knows Quality Management Systems from cover to cover. The Factory Good Manufacturing Practices (GMP) Audit is a requirement for all factories and packaging operations making products for Costco Wholesale. The factory GMP audits are site specific and are not connected to specific products.
We follow our repeatable and reliable process to help non-food businesses get the certifications you need.
During your Costco Non-foods GMP consultation, you’ll learn what the requirements are for getting certified, how long it takes, and how our process works to assure you pass Costco’s GMP certification audit on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process. You will be fully prepared to pass your Costco audit.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your Costco Non-foods GMP, you employees will receive a professional and specific training log.
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Since 2021, our HACCP Consultants have assisted 150+ clients throughout the food industry and we’ve seen it all. To be compliant at your FDA, USDA or state-inspected facility, you need to have a documented HACCP Plan and Food Safety Program.
What does HACCP mean? Hazard Analysis Critical Control Point (HACCP) is defined by the F.D.A. as “a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product”.
Our HACCP consultants write and implement your HACCP Plan and Food Safety Programs, train you, and stay with you until your HACCP Plan and Food Safety Program are approved.
During your HACCP Plan and Food Safety Program consultation, you’ll learn what the requirements are for being in compliance with HACCP CxC 1-1969, Revision 2020, how long it takes, and how our process works to assure you pass your inspection on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
What is a HACCP consultant? Our HACCP Consultants follow the full 12 step HACCP process. We consult with your team, construct a flow diagram & validate it, conduct the hazard analysis, determine the critical control points (CCPs), establish critical limits, establish corrective actions & verification procedures, and establish documentation and record keeping. We train you to follow the full HACCP food safety program that is tailored to your facility.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your HACCP, you employees will receive a professional and specific training log.
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We Develop and implement Dietary Supplement certification programs, including current good manufacturing practices (cGMP) & compliant with NSF/ANSI 455-2 & 21 CFR 111 (& accepted by Amazon & other major retailers). Our clients’ dietary supplement certification success rate is 100% because we stay with our clients until you pass, no matter what.
Our dietary supplement consultants are responsive, straightforward, and dedicated to our clients.
During your Dietary Supplement Certification Program consultation, you’ll learn what the requirements are for being in compliance with good manufacturing practices (cGMP) & compliant with NSF/ANSI 455-2 & 21 CFR 111, how long it takes, and how our process works to assure you pass your inspection on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with. Our team of expert food safety & dietary supplement consultants knows what it takes for your products to get certified.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your Dietary Supplement Certification Program, you employees will receive a professional and specific training log.
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GlobalSTD’s GMP consultants provide a written quality & food safety manual that is tailored to your product, process and operation. We provide quality consulting and food safety training according to current FDA regulatory requirements and customized to the GMP certification scheme that you are wishing to get certified against. You will receive project management services and we will stay with you until you pass your audit – no matter what.
Good Manufacturing Practices (GMPs) are also referred to as prerequisite programs, or food safety and quality fundamentals. These are the site and company specific rules and daily activities put into place to keep products safe. GMPs may be written down or communicated verbally and are generally enforced through Quality Assurance or management personnel. GMP certification audits have fewer requirements than GFSI audits and are considered a stepping-stone to get to a GFSI certification. There are many factors to consider when weighing which certification is right for you, and we can help you choose the most appropriate certification scheme for your business goals.
cGMP is a step-up from GMP standards and is required for dietary supplement manufacturers. cGMP means Current Good Manufacturing Practice. cGMP regulations require additional product testing and more thorough quality management systems in place.
GlobalSTD has supported hundreds of clients nationwide to successfully pass their regulatory inspections and their GMP and cGMP certification audits.
The FDA does not provide certification, however, they do provide GMP regulatory oversight for the majority of food manufacturers (except for meat, poultry and egg product manufacturers which are overseen by USDA). USDA provides regulatory compliance guidance and certification services in limited circumstances, such as, for the USDA Specialty Crop GMP Audit Standard.
Being in compliance with GMPs or cGMPs is not the same as being certified. In order to gain GMP or cGMP certification, you must hire a third-party auditing company to evaluate your practices against GMP or cGMP standards. Many companies choose to hire consultants to provide business support services to properly prepare for certification audits . Kellerman Consulting will write & implement food safety and quality programs that are tailored to your product and process.
Since 2021, our Good Manufacturing Practices (GMP) consultants have assisted many of clients throughout the supply chain to get GMP certified. GMP is an important foundational system required of many manufacturers to ensure products are consistently produced to a high standard. Our results-driven team will write and implement your GMP program, train you and stay with you until you pass your GMP certification audit.
Ace your GMP Audit with a family-run team who knows food safety and quality management systems cover to cover.
During your Good Manufacturing Practices (GMP) consultation, you’ll learn what the requirements are for being in compliance with good manufacturing practices GMP, how long it takes, and how our process works to assure you pass your inspection on the first try.
How do we do it? By working closely with your team and by following our repeatable and reliable process.
All of our consultants are well-versed in GlobalSTD’s repeatable and reliable process. Our team’s collaborative culture gives you the benefit of our collective experience with hundreds of successful outcomes. You will achieve the same 100% success rate regardless of which of our team members you work with. Our team of expert food safety & dietary supplement consultants knows what it takes for your products to get certified.
You benefit from the support of consultants who review every project as a team. The founders of GlobalSTD Consulting are involved with each project at every stage to make sure that we are delivering on our commitment to our clients.
Our consultants respond immediately to all client questions, which reflects one of our core values. GlobalSTD team members are kept up to date on every project, so that any one of our consultants can easily step in at any moment to give you the reliability and responsiveness your project deserves.
In addition to your GMP, you employees will receive a professional and specific training log.
+ Click to Zoom
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