It's More Than Just Locating a Contract Manufacturer

The Common Misconception

There is a common notion that once brand owners sign a contract with a manufacturer that the regulatory burden falls on them. However, this is not the case. The brand owner is responsible for what reaches the hand of the consumer. Finding a contract manufacturer appears to be the easy part, but locating one that produces a quality product and meets all the regulations to manufacture is more challenging. You need a consultant that not only knows these criteria but can also build the processing from the ground up.

The Compliance Gap

It is shocking how many new, and small contract manufacturers operate without programs in place for quality and regulatory compliance that meet the current government standards. In most cases, these manufacturers are unaware of such regulations. If both you and the manufacturer are oblivious to them this can lead to high risks, like product recalls, FDA warning letters, or seized inventory, and potentially damage the reputation of the brand itself. 

The Legal Reality

As a brand owner, whether you own the machinery or not, you are responsible for the safety and transparency of the product. It is left to the brand owner to verify that the manufacturer has quality programs, testing protocols, and environmental controls to meet the federal standard. 

Your Rights as a Partner

Your position as the brand owner grants you rights that are non-negotiable in a partnership. You should have access to batch records, review quality test results and see the manufacturing site itself.

Building a Partnership

Overall, it’s important to build a successful partnership where both work together to create a good quality product, through collaboration and transparency.