FDA registered · GMP certified · Carroll County, Georgia
Guide

FDA registered and GMP certified: what they mean

The two phrases appear on almost every manufacturer's website. They mean quite specific and quite different things, and neither means what most people assume.

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.

GMP certified

Current Good Manufacturing Practice is the set of requirements covering how a supplement is actually made: documented procedures, trained personnel, equipment calibration and maintenance, raw material testing, in-process and finished product testing, sanitation, and complete batch records. Certification means an auditor has checked the facility against those requirements.

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. They describe how carefully a product was made, not what it does. Those are your responsibility as the brand.

Why batch records keep coming up

Traceability is the thread running through cGMP. If a raw material is later found to be a problem, batch records are what 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 GMP certified, and keeps batch records with full traceability. SQF certification is in progress: planned, not held today, and described that way throughout.

Services this applies to

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.

Request a quote
Get started

Ready to bring your formula to life?

Tell us the format, the volume and the timeline. We will come back with a custom quote.

Request a quote Our certifications
Botanical capsules in a glass jar