Is my contract manufacturer actually compliant — or am I on the hook if they are not?
FDA holds the brand owner responsible for the product bearing its name, even when a contract manufacturer made it. “FDA compliant” is not a certificate anyone issues, so the only way to know is to review the manufacturer’s actual registration, inspection, and quality records.
What does “FDA compliant” actually mean?
Nothing, on its own. FDA does not certify, approve, or endorse manufacturing facilities. Facilities register with FDA, and FDA inspects them. Registration is a filing, not a grade. A facility can be validly registered and still have open Form 483 observations or an unresolved warning letter.
If the manufacturer fails, why am I exposed?
Because the product carries your name. If the batch records, testing, or controls behind your product do not hold up, the product itself is adulterated or misbranded — and that is your product. You may have contract remedies against the manufacturer, but those are separate from, and slower than, FDA’s interest in the labeled product.
What should you ask a contract manufacturer for?
The FDA establishment registration number, the date and outcome of the last FDA inspection, copies of any Form 483 observations with the closeout documentation, the applicable GMP standard they operate to, and their change-control and deviation procedures.
What belongs in a quality agreement?
Product specifications, who performs and pays for testing, which changes require your prior written approval, notification timelines for deviations and out-of-specification results, record-retention obligations, audit rights, and how a recall decision gets made.
Why does this surface during acquisitions?
Because diligence teams ask for exactly these documents. A brand with no quality agreement and no manufacturer inspection history is a valuation problem, and it is usually discovered in the first two weeks of diligence.
Video Transcript
Your contract manufacturer says they are FDA compliant. If they are wrong, who pays for it? You do, at least in part. FDA holds the brand owner responsible for the product that carries its name, even when someone else manufactures it. “FDA compliant” is not a certification anyone issues. A facility can be registered with FDA and still fail its next inspection. If your manufacturer’s records do not hold up, the product with your label on it is what gets called adulterated or misbranded. Retailers and acquirers now ask for this documentation directly, so the gap tends to surface at the worst possible moment — during due diligence. Get their FDA establishment registration number and verify it yourself rather than taking it on faith. Ask for the outcome of their last inspection, any FDA Form 483 observations, and how each was closed out. Put specifications, testing responsibilities, and change-notification duties into a written quality agreement. If you have never verified any of this, contact us today.
FAQ
Q: Can I rely on my manufacturer’s certificates of analysis?
A: They are useful evidence but not a substitute for your own oversight. A COA reflects one test on one sample.
Q: Do I have the right to audit my manufacturer?
A: Only if your agreement says so. Audit rights are one of the most commonly omitted provisions.
Q: Is a quality agreement the same as a supply agreement?
A: No. The supply agreement covers commercial terms; the quality agreement covers technical and regulatory responsibilities. You want both.
Q: What if my manufacturer refuses to share inspection history?
A: That refusal is itself information. Many manufacturers now share it routinely, particularly when a brand’s counsel asks.
Q: How often should this be re-reviewed?
A: At least annually, and any time there is a formula change, supplier change, packaging change, or a change in the manufacturing site.
Talk to an FDA Compliance Attorney
Talk to an FDA compliance attorney before a problem becomes a recall, a hold, or a lost contract. Contact Capote Law Firm today.
- Related video: Why “My Contract Manufacturer Handles Compliance” Is the Assumption That Gets Distributors Burned
- Related video: The Compliance Gap That Shows Up the Moment a Bigger Company Acquires Your Business
- Service page: Supplier Qualification and Quality Agreement Review
This content is provided for educational purposes only and does not constitute legal advice. For guidance specific to your situation, please contact us.