FDA FSMA
Every food facility that’s required to register in accordance with Section 415 of Food, Drug & cosmetic Act unless exempted. This includes food manufacturers, processors, packers, and facilities that hold food for human consumption.
Qualified facilities, low-acid canned food facilities, juice manufacturers (HACCP), seafood processors (HACCP), dietary supplements and alcoholic beverages.
The FSMA regulations are mandated by the law. The ramifications for not complying could range from recalls, warning letters, penalties to law suits, suspension, and criminal charges.
The type of trainings that the employees of the food facilities must undergo varies depending on the activities of the food facility. In general, the employees/employee must undergo PCQI Training, FSVP, HACCP, GMP, Food Defense and basic food handlers training.
A qualified facility is a business that is required to meet less stringent and modified rules due to its small size and/or revenue.
Yes. A FSMA regulated food facility must have at least one PCQI always present during production, processing, packing, or holding foods for consumption
No, it is not mandatory assuming that the facility does not deal with juice, seafood, and low-acid canned products.
It is a voluntary scheme. But the facilities must meet the cGMP requirements.
FSVP
FSVP stands for Foreign Supplier Verification Program which aims to ensure that the foreign companies supplying foods to the US meet the FDA FSMA regulations. It is every FSVP importer’s responsibility to ensure that their suppliers meet the FDA standards.
Every food facility in the US that imports foods from foreign countries and are bound by the FSMA rules.
Foods not intended for sale or distribution in the US.
Food facilities that are regulated by FDA HACCP
Alcoholic beverages (under some conditions)
Some meat, poultry, and egg products
A US agent is responsible for helping FDA to communicate with the foreign food facilities and assisting foreign facility inspections. Whereas, and FSVP agent is responsible for maintaining the food safety related documentation of the foreign suppliers in the US. FSVP agents are responsible for verifying the foreign suppliers.
Being certified against a GFSI scheme assures that suppliers meet most of the FSMA requirements but not entirely. There still might be a need to bridge gaps between GFSI benchmarked certifications and FSMA regulations.
HACCP
The FDA mandates the creation of a HACCP plan for any food production facility that produces juice or seafood products. Additionally, meat and poultry food facilities must have HACCP plans, in accordance to the USDA FSIS regulations..
Hazard Analysis and Risk-based Preventive Controls (HARPC) applies to all the food facilities covered by FDA FSMA except juice processors and seafood processors, who fall under the FDA Hazard Analysis and Critical Control Points (HACCP) regulations.
Yes, if your food facility is not exempted by the FSMA regulations.
HACCP is a voluntary program for food service chains and restaurants.
HACCP plans must be reviewed at least once a year and revised as needed.
HACCP plan is not sufficient to meet the FSMA FSVP requirements, unless the supplier is a juice or a seafoodprocessor in which case they are exempt from FSVP requirements.
GFSI Consulting
GFSI stands for Global Food Safety Initiative. GFSI is a private coalition made of major consumer goods conglomerates to set industry standards for food safety. GFSI recognizes food safety certification schemes like SQF, BRC, IFS, and FSSC 22000 that are robust and increase consumer confidence. Major retailers around the world are increasingly accepting only GFSI recognized certification from their suppliers.
The major food safety schemes recognized by GFSI are SQF, BRCGS, FSSC 22000, Global G.A.P., IFS Food Standard, and PrimusGSF.
GFSI benchmarked certifications meet majority of the FSMA requirements but not all of it.
GFSI certified helps food manufacturers and processors to stay competitive, produce safer products, and improve the overall performance of the company. GFSI recognized certifications are being adopted at an increasing rate in the industry. To stay relevant and competitive in market, it is almost imperative to be certified against a GFSI benchmarked standard.
GFSI recognized standard like SQF, BRC and FSSC 22000 are based heavily on HACCP, whereas FSMA is based on HARPC. Though SQF, BRC, and FSSC 2200 are a lot more comprehensive, FSMA necessitates a different type of food safety plan than that of basic SQF, BRC and FSSC 22000.
GFSI recognized schemes are a voluntary program. But it gives a great competitive advantage to food packaging manufacturers if they are certified against a GFSI scheme like BRCGS- Packaging.
Food Safety Training
Mandated food safety trainings vary by the states and counties in the US. But generally, food handlers training, food protection manager training, and PCQI training are strongly recommended by the regulations. The trainings also differ by the type of food facility (manufacturing, packing, food service, processing)
There is no expiry date for the PCQI certificate, but refresher trainings are recommended every 1 to 2 years.
There is no expiry date for the FSVP certificate, but refresher trainings are recommended every 1 to 2 years
Refresher trainings are a type of retraining where previously qualified candidates get to review the concepts and get updated on changes, if there are any.
Yes, GHP can provide on-site trainings anywhere in the United States.
General Food Safety & Quality
Internal audits are when the organization self-assesses its own food safety management system to ensure conformance to the relevant standard. Internal audits must generally be conducted quarterly.
Supplier audits are when buyers visit the facility of their supplier to check the integrity of their food safety management system. Supplier audits must be conducted at least once a year for high-risk food suppliers.
Gap Audits are conducted to check the gaps or non-conformance in the food safety management with the aim to achieve compliance against a certain standard or guideline and to improve the system. Gap audits are usually conducted before the implementation of a food safety program.
Food facilities are strongly recommended to review their food safety plan and the food safety management system at least once a year. But organizations must revise their food safety plan and/or other pertinent documents immediately when there is a change in their process, new ingredients are added, and if a new equipment bought.
GHP’s yearly food safety packages are intended to assume majority of the food safety burden of an organization. The yearly food safety packages are tailored to be affordable and convenient for food companies. The packages include all types of food safety support services necessary to the meet the FSMA regulations, and alsothird-party certifications like SQF, BRC, and FSSC 22000. This way companies will always be audit-ready and inspection-ready.
FDA Registration
Every food manufacturer, processor, packer, and facility that holds food for human consumption must register with the FDA.
Yes, US agents can register foreign food companies and act as the point of contact between the FDA and the foreign supplier.
In addition to the regular food facility registration, low-acid canning facilities must register separately as Food Canning Establishment (FCE), without which the canned products cannot be sold in the market.
SID stands for Submission Identifier. Every food canning establishment must create a SID for the different processes and products in its facility. Without the SID, products should not be released to the market.
Yes, GHP can review nutrition label for FDA compliance.
Facilities dealing with human food will be considered a “qualified facility” if it meets the definition in 21 CFR 117.3.
FDA Form 483
FDA 483 is a form issued by the FDA inspector to the inspected facility after inspection. It lists out the observations and non-conformances identified by the FDA inspector.
Food facilities that received warning letters from FDA must respond to them within the specified period. The organization must close all the non-conformances identified by the FDA inspector as soon as possible to avoid suspension or legal consequences. GHP can help food facilities address Form 483 and warning letters.
The mode of communication will be discussed by the FDA inspector after the inspection.
FDA can act on the food facility in different ways depending upon the serious on the non-compliance. It could range from warning letters, penalties, suspension to litigation and consent decree.
Take regulatory compliance seriously, self-assess your facilities’ food safety system regularly. Hiring a 3rd party food safety support like GHP could help you identify the gaps and get in compliance when a deviation occurs.
Facilities dealing with human food will be considered a “qualified facility” if it meets the definition in 21 CFR 117.3.