The FDA expects a formal quality agreement between every brand owner and contract manufacturer. If you don't have one—or yours is vague—you're exposed. Here's what it must cover, and what most brand owners miss.
Under 21 CFR Part 111, brand owners who outsource manufacturing to a contract manufacturer (CMO) are still fully responsible for GMP compliance. The FDA's mechanism for enforcing that responsibility is the quality agreement—a binding document that defines who does what, who owns which records, and how quality failures get resolved.
Without a quality agreement, an FDA investigator has no basis to conclude you exercise any oversight of your CMO's manufacturing operations. That gap is routinely cited in Warning Letters and Form 483 observations.
⚠️ A purchase order is not a quality agreement. A vendor questionnaire is not a quality agreement. The FDA looks for a signed, comprehensive document that covers roles, procedures, and accountability—not a checkbox on a supplier form.
A compliant quality agreement between a brand owner and CMO must address each of the following. Enter your name and email to access the full checklist—we'll also send a copy to your inbox.
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Check each of the following against your current quality agreement—or against the blank page if you don't have one yet.
Explicitly assigns ownership for every key quality activity: who approves batch records, who handles deviations, who initiates and closes corrective actions. Ambiguity here is the single most common source of Warning Letter observations—investigators need to see that someone is clearly accountable for each function.
References product specifications—identity, purity, potency, physical attributes—and defines the acceptance criteria used for release. The agreement should specify who sets the specs (typically the brand owner) and who tests against them (typically the CMO), with both parties signing off on the approved versions.
Defines how changes to formulas, manufacturing processes, raw material suppliers, or packaging are communicated and approved. Brand owners who are surprised by CMO changes—and cannot show a documented review process—cannot demonstrate oversight. This section protects you from your CMO making undisclosed changes.
Specifies how consumer complaints and manufacturing deviations are reported between parties, the timeframes for notification, and who leads the investigation. FDA investigators expect brand owners to have records of complaints and deviations—even when the CMO is the one who discovered them.
Requires a periodic review of the quality agreement itself (typically annually) and of key product quality data. This documents ongoing oversight rather than a one-time setup exercise. Most agreements are signed and filed—this provision forces active engagement with the relationship every year.
Grants the brand owner (or their designee) the right to audit the CMO's facility, records, and quality systems, typically on reasonable notice. Without this clause in writing, your CMO can legally refuse an audit request. This is the most commonly missing provision in brand owner quality agreements.
Defines who is responsible for qualifying raw material suppliers and component vendors—the CMO, the brand owner, or shared responsibility with defined handoffs. If your CMO sources raw materials and you have no visibility into how they were qualified, you have a gap the FDA will find.
Documents who has final authority to release finished product for distribution. Brand owners commonly assume the CMO handles release—but the FDA expects brand owners to have a documented review step before product ships under their label. This must be explicit in the agreement.
Specifies which party retains which records, for how long, and what access the other party has. Under 21 CFR Part 111, batch records must be retained for at least one year past the product shelf life. The agreement must clarify who holds these records and ensure brand owner access in the event of an FDA inspection.
Even brand owners who have a quality agreement in place often have these critical omissions. Each one is a documented finding in FDA Warning Letters.
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