You would like to market a dietary supplement and you need to vet a contract manufacturer (CM) to build a final product for you. In the eye of FDA, the marketer is as responsible as the contract manufacturer to insure that the finished product is safely made and pass muster.

You need to vet the contract manufacturer and there are many questions to ask your future partner.

Examples of these include:

• Does the contract manufacturer have standard operating procedures (SOPs) for manufacturing, quality, documentations, recalls?

• Has the contract manufacturer ever been inspected by FDA or any other state/federal agency? What was the result of these inspections? Likewise, have they ever received a warning letter?

• Has the contract manufacturer ever been party to a lawsuit as a defendant and it (or its insurance company) had to pay out a settlement?

• Who owns the formula that they are building for you?

And so on.

The bottom line is that you need to vet a contract manufacturer and have an iron clad agreement with the CM that clearly outlines the responsibility on each side and leave no areas for guesses. Asking for professional help at the beginning of the process will save for later headaches or worse later on.