Focus on Quality

Bloom & Blossom is produced in a world-class facility. Our formula meets FDA requirements, the nutritional levels recommended by the American Academy of Pediatrics (AAP), as well as the highest expectations of our most important customers: moms and babies.

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Quality of Baby Formula and a Heritage of Trust

At Bloom & Blossom, we understand quality of baby formula products is of the utmost importance and on the minds of parents. Quality Assurance (QA) is integral to our mission of providing a complete, sole-source nutrition to growing infants. Our Ultra Gentle Infant Formula meets the high expectations for safety and effectiveness held by our customers, employees, stakeholders, and regulatory agencies worldwide.

Bloom & Blossom Manufacturing Plant

Our infant formula factory has a long and trusted heritage dating back to Wyeth Nutritionals. It is one of the only ISO 9001:2015-certified facilities of its kind in the United States. The factory is inspected annually by the Food and Drug Administration and meets FDA nutrition, quality, and safety standards, as well as a stringent set of quality-assurance regulations set by the International Organization for Standardization.

A focus on Safety and Quality, 24 Hours a Day, 7 Days a Week

The state-of-the-art facility, which has been producing powder infant formula for more than 30 years, operates 24 hours a day, seven days a week, and employs more than 350 people who are committed to manufacturing safe, nutritionally complete, Ultra Gentle Formula for babies across the nation.

Approximately 20,000 infant formula quality inspection tests are conducted each month; our packaging process alone requires approximately 27 on-line quality inspections with operations checking 589 different quality elements.

QA and Safety Certifications

The Bloom and Blossom manufacturing plant and teams maintains numerous infant formula safety and quality certifications that appeal to different customers. From good manufacturing practices and FDA compliance to organics and special dietary requirements, we make certain our operations adhere to the highest quality and safety standards.

  • Bloom & Blossom Ultra Gentle Formula is certified kosher by the Orthodox Union (OU). This means our infant formula may be consumed by all those who observe kosher dietary laws, as well as by many others who have special dietary requirements.
  • Our factory is fully compliant with the Safe Quality Food (SQF) Program. SQF certifies a supplier's food safety and quality management system complies with international and domestic food safety regulations.
  • We maintain strict compliance with good manufacturing practices and operate a cGMP facility.
  • The factory is also approved by Quality Assurance International (QAI) to manufacture organic formula that is compliant with comprehensive USDA organic regulations.
  • Bloom & Blossom meets the nutritional requirements of the Federal Food, Drug, and Cosmetic Act for infant formula under the regulation of the FDA.
  • Ultra Gentle Formula also meets the nutritional levels recommended by the American Academy of Pediatrics (AAP), the largest organization of pediatricians dedicated to the health and well-being of infants and children.

Bloom & Blossom is produced in a world-class, highly automated manufacturing facility located in close proximity to local dairy farms. Quality systems are at the core of the technology that drives our manufacturing processes from beginning to end. Below is a brief outline of our quality systems in action during the manufacturing process.

A Brief Outline of Our Process

Bloom & Blossom manufactures a specialized formulation using the most sophisticated processing controls and manufacturing equipment in the world today. Highly secure with biometric sensors located throughout the facility, our plant equipment and controls systems allow team members access to different zones of the plant based on requisite training and security clearance.

The plant creates and maintains a positive-pressure, HEPA-filtered manufacturing environment that minimizes risk of product contamination by microscopic organisms. We accomplish this using a highly sophisticated, fully integrated pressurization and environmental control system complete with unique zoning that isolates sensitive areas to prevent cross-contamination from the external environment.

The manufacturing process begins in Receiving, where raw materials are taken from shipping trucks, stored in the warehouse for inspection, and released by Quality Assurance inspectors for Mixing. The QA department inspects all raw ingredients that are received from suppliers according to strict criteria for safety and quality.

Upon QA Release, raw materials enter the Mixing phase of the production process, where ingredients are sent to Liquefying, Oil Storage, Fat Blending, and Micro Ingredient Dispensing Unit processing. Materials are blended using water from sophisticated reverse osmosis technology in which the water is refined to a level of less than 0.1 ppm fluoride.

During Compounding, liquefied ingredients are mixed with fat blends, nucleotides, essential nutrients, and minerals and go through extensive heat treatment, homogenization, cooling, and then storage in mix tanks. In addition, heat-sensitive vitamins are added at this point in the process. The liquid product is again tested by the QA department and released for additional processing.

From mix storage, the formula ingredient blend is concentrated, via an evaporator, before entering the drying process.

Our distinctive drying technology facilitates tight regulation of moisture, reconstitution, and bulk density of the product. Our dryer is fitted with a million-grid matrix to optimize any formulation that we produce based on advanced Finite Element Analysis. This technology enables us to predict ideal conditions for any product, which saves thousands of processing hours and development time while ensuring custom products tailored to the needs of our customers that can be manufactured with recurring consistency and quality.

Finished product from the dryer is then transferred to powder storage, where it stays until the QA department once again tests and releases powder formula so it can be packaged.

In Packaging, infant formula is placed into a SmarTub® formula container and sealed to protect product integrity and freshness. To guarantee product integrity, oxygen is purged from all infant formula products in a nitrogen environment.

After product has been packaged in individual containers, they pass through an ink jet coding step to guarantee proper identification and traceability. Packaged formula then enters a labeling, insert and over cap process, before being sent to case or tray packing.

Once labeled, infant formula is placed in cases or trays, sent to ink jet printers again for carton/tray printing, before moving on to the palletizers and stretch wrappers.

After product is stretch-wrapped on pallets, it is sent to the warehouse pick-up point, where Material Handlers apply identification tags to the pallets before they are placed in storage.

Product is then inspected again by the QA department and released for shipping to world markets.

processing controls and manufacturing equipment
product is inspected by QA department
QA department once again tests and releases powder formula so it can be packaged
product is strictly monitored by using the most sophisticated processing controls system