NutraStar is a local manufacturer that specializes in producing custom formulated tablets, capsules, and powders for nutraceutical brands. Located in Farmingdale, New Jersey, NutraStar has a staff over 250 employees on site and they manufacture 10 million capsules, 100,000 bottles, and 10,000 kg of custom formulated powder per day out of their 60,000 square foot production facility. They are one of the top contract manufacturers for leading supplement brands. NutraStar manufactures their custom formulations using the highest-quality raw materials.
NutraStar was looking for a partner that can help them remain compliant with both the UL and FDA. The FDA recently started requiring food manufacturers to follow the food defense regulations to be considered compliant and receive their GMP certification. Without the GMP certification, it would be difficult for them to continue operating. Customers have requested NutraStar have the certification before continuing business with them. Customers will check for the certification on a third-party database.
Our customers ask us, ‘What was your score from your last audit?’ when it’s a hundred, a certain level of interest and business goes to a whole new level. They look at us differently and in general, the market would look at us differently because they see that we’re taking our quality very, very seriously and we are sincere about what we do and what products we make and how we make those products. NJMEP played a vital role in that. Our customers are happy and it made our employees happy because everybody now feels a part of an organization that prides over their quality. Prides over how they manufacture our products. So, it was a win-win for employees and for customers.
NutraStar explored options to upskill their staff and become certified by the FDA’s upcoming deadline and discovered NJMEP, part of the MEP National Network™, has the expertise that would address all their needs. They reached out to NJMEP for help and explained their challenge to the NJMEP account manager.
Their account manager is familiar with the regulations, the timeframe needed for preparation, and its importance. The account manager knew they didn’t have much time to prepare so he worked with NutraStar’s team to quickly develop a plan. A plan was created immediately after the account manager surveyed their facility and staff and saw how much time they would need for food defense training and certification.
Training took a total of 12 hours to complete including the eight hours of on-site training and four hours of training customization. The training’s focus was on the physical structure for food defense elements to help better explain 21 CFR 121 regulations. Working with a knowledgeable consultant to come up with a quick plan allowed NutraStar to have food defense certification before the deadline, become GMP certified, and ultimately continue their business with customers.