FDA registration and SQF Fundamentals: what they mean
Our facility is FDA registered and certified to SQF Fundamentals for Manufacturing - Intermediate. Here is what each means for your manufacturing partner.
FDA registered
A facility that manufactures dietary supplements registers with the US Food and Drug Administration, which makes it known to the agency and inspectable by it. Registration is a requirement, not an award. It does not mean the FDA has approved, endorsed or tested any product made there. The FDA does not approve dietary supplements at all.
SQF Fundamentals for Manufacturing - Intermediate
SQF Fundamentals is a food safety program for manufacturing. The Intermediate level builds on the Basic Code with additional documentation requirements. It provides a foundation for a food safety management system.
What neither one tells you
Neither says anything about whether a formula works, whether a claim on the label is supportable, or whether an ingredient is worth taking. FDA registration identifies the facility to the agency; SQF Fundamentals certification addresses its food safety system. Neither is approval of an individual product.
Why batch records keep coming up
Traceability connects raw materials to finished products. If a raw material is later found to be a problem, batch records tell you which lots it went into and where they went. It is unglamorous and it is the single most useful thing a manufacturer can hand you.
Where this lands with us
This facility is FDA registered and certified to SQF Fundamentals for Manufacturing - Intermediate, and keeps batch records with full traceability.
Tell us what you want made
Send the formula, the format and the run size you have in mind. We will come back with real numbers.
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