Facility Compliance and Certification
The list of products that fall under FDA regulation is extensive, ranging from supplements, candy and canned goods to food for animals, food for humans, and more. What these diverse groupings all have in common is how they’re protected within the US. According to the Code of Federal Regulations (CFR), all domestic and foreign facilities that manufacture, process, pack, and/or hold food for human or animal consumption in the United States must register with the FDA.
Keeping Your Products, and the People Who Buy Them, Safe and Secure.
ShipMonk is dedicated to upholding all FDA regulations so our clients and their customers can rest easy. We also ensure all our relevant facilities are GFSI certified, which means they adhere to a premier set of food safety guidelines that ensure facilities are safely handling related products.
Certification requires an intensive auditing process involving international food safety management systems and auditing companies. Getting GFSI certified isn’t easy, but at ShipMonk we prioritize anything that enhances our clients’ businesses peace of mind and potential for success. In this case, GFSI certification lets our clients and their customers be confident that the products we store and fulfill are handled with the highest level of care.
Continue reading about FDA requirements and GFSI certification below to understand just how seriously we regard this responsibility.
What Is the FDA?
The Food and Drug Administration (FDA) is responsible for ensuring the security and safety of United States public health in relation to: food, beverage, biological products, cosmetics, drugs, veterinary products, medical devices, and products that emit radiation.
All facilities in the US handling products that fall under this list must be registered with the FDA. Registration must be renewed every two years, and all participating facilities grant the FDA permission and access to inspect their grounds, which typically occurs once every three years. In general, these standards safeguard citizens against products that could be harmful to health, food-related emergencies, and bioterrorism.
FDA-Registered Fulfillment Facilities
With a wide array of fulfillment centers storing and shipping products for ecommerce businesses of all sizes across all verticals, it is vital that ShipMonk abide by, and be up to date on, all FDA requirements. All eight of ShipMonk’s US-based facilities are currently registered with the FDA and are consistently renewed in perpetuity.
When registering a site with the FDA, different categories are selected for the type of item being stored. For example, Coffee, Food for Animal Consumption, and Cosmetics, are all different category types. Medical devices have additional regulations attached, especially if a business requests the warehouse storing them perform any re-packing or re-labeling.
Note – FDA registration must be updated if a new category of product is brought onsite to any facility.
According to CFRs, certain finished FDA (registered, approved, or monitored) products must be stored under conditions that will preserve the products’ identity, purity, strength, and composition. Those products may include food, dietary supplements, cosmetics, and medical devices. ShipMonk facilities are committed to adhering to our clients’ temperature needs.
It is the responsibility of every client to clearly establish temperature, humidity, and light requirements prior to inventory arriving at a fulfillment center so ShipMonk can ensure that goods are warehoused in the proper facilities. For example, ShipMonk has three fulfillment centers with temperature-controlled storage: New Jersey, Nevada, and Texas. Therefore, if an ecommerce brand sells products that require temperature-controlled storage in the US, orders would need to be fulfilled from one of these specialized facilities.
Note – warehouses and temperature-controlled storage areas do not have temperature mapping. However, temperatures are being monitored and logged in those areas.
ShipMonk’s cGMP Standards
Current Good Manufacturing Practices (cGMP) consists of all processes, procedures, and documentation that ensures food, cosmetics, and pharmaceutical goods are consistently produced and controlled according to set quality standards. ShipMonk cGMP procedures and documentation are maintained in our advanced Quality Management System. A list of current procedures is available per client request.
What Is the GFSI?
The Global Food Safety Initiative (GFSI) is an initiative for the development of food safety management systems that ensure food facilities are processing safe food for consumers.
Prior to the creation of the GFSI, retailers would perform inspections themselves or recruit a third party to perform audits at food facilities where their products were being manufactured or stored. This required a food facility to be audited by various customers for the same requirements.
Following a series of high-profile food recalls in 2000, GFSI was launched to restore confidence in the food and beverage industry and develop an internationally-recognized benchmarking system for food safety. GFSI unveiled a series of standards for companies to live up to. The result: customers can be more confident in a facility, which reduces the need and desire to conduct additional audits themselves.
What Does It Mean to Be GFSI Certified?
Manufacturing sites, distribution sites, and storage sites for food products are considered GFSI certified if audits prove they adhere to the established GFSI quality guidelines. This type of certification is based on site, not brand, which means the site(s) a brand uses can be GFSI certified, but the brand itself is not. Hence the need for every site a brand uses to undergo separate GFSI certification audits.
There are a couple of key players involved in ShipMonk’s GFSI certification. British Retail Consortium Global Standard (BRCGS) is an international food safety management systems entity that GFSI recognizes to ensure a location is meeting GFSI requirements. A significant part of the BRCGS includes cGMP, referenced above. AIB International is an auditing company that verifies if sites meet BRCGS requirements. In order to be GFSI certified, ShipMonk is using AIB International to ensure site compliance to BRCGS.
Audits occur annually and can be unannounced, which ensures facilities are always up to par with GFSI guidelines. At ShipMonk, additional internal audits are conducted at each site quarterly. Internal audits can be unannounced as well. Since unannounced audits are a part of the program, it is very important for sites to maintain compliance to standards at all times. Each ShipMonk fulfillment center has a Quality and Compliance representative involved in the audits with access to the Quality Management System for maintaining the site’s GFSI certification.
Certified for Success
At ShipMonk, we’re known for our mission to help ecommerce brands “stress less and grow more.” We hope that learning about our strict adherence to FDA regulations and commitment to GFSI certification removes stress when it comes to the safety of your products. For more information about ShipMonk, visit our certifications page or contact us today to get started. And to learn about our commitment to data safety standards visit our SOC Compliance Certification page.