Quality Agreements: What Brand Owners Need to Know

Why You Need a Quality Agreement

Under 21 CFR Part 111, each firm must meet the requirements that apply to the operations it performs. If a contract manufacturer makes a supplement that you distribute under your own label, FDA's preamble to the rule says you must know what manufacturing activities are performed and how, so you can decide whether the product conforms to your specifications and whether to release it for distribution. That holds even when the manufacturer made, tested, and packaged the product. The rule's retail exception for holding does not reach your warehouse: under 21 CFR 111.1(b), a retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

A quality agreement makes this shared responsibility explicit. It defines what the manufacturer does, what you do, and what happens when something goes wrong. Without one, every quality problem becomes a negotiation instead of a defined process.

FDA publishes, by fiscal year, how many times each regulation was cited on the inspection observation forms (483s) its system generated. In fiscal year 2025, the three dietary supplement provisions cited most often were not establishing finished-product specifications (21 CFR 111.70(e), 188 times), not establishing component specifications (21 CFR 111.70(b), 177 times), and batch production records missing required information (21 CFR 111.260, 103 times). Specifications and batch records are documents a quality agreement should assign: name who writes, approves, and keeps each one.

Quality Agreement vs. Manufacturing Agreement

These are separate documents with different purposes. Mixing them creates confusion during quality events.

Key Sections of a Quality Agreement

Every quality agreement should address these areas. The detail level depends on your product complexity and the manufacturer's capabilities.

Negotiating Your Quality Agreement

Your contract manufacturer may already have a template quality agreement. That template protects the manufacturer. Your job is to read every section and negotiate the terms that protect your brand.

• Start with their template, then revise. Don't write one from scratch. The manufacturer's template reflects their actual processes. Revise it to add your requirements rather than creating a document that doesn't match how they operate.
• Get your own quality person involved. If you don't have a quality team, hire a quality consultant to review the agreement. This is not a document for your business attorney alone. Quality agreements require regulatory expertise.
• Define testing specifications, not just 'industry standard'. Vague language like 'meets industry standards' gives neither side a clear test to hold the other to. Specify exact test methods, acceptable ranges, and limits for every ingredient and finished product parameter.
• Require notification before changes, not after. Read the change control section most closely. A manufacturer who switches your vitamin C supplier without telling you has created a compliance risk you didn't consent to.
• Include a retention sample clause. 21 CFR 111.83 requires reserve samples of each lot of packaged and labeled dietary supplements that you distribute. Say in the agreement who that is. A contract manufacturer returning product to you may not be the distributor, so the duty may sit with you. The period is one year past the shelf life date, when shelf life dating is used. When it is not, it is two years from the date the last associated batch was distributed. Assign the duty and the retention period in the agreement, and name who can draw on the samples. These samples allow investigation if a quality issue surfaces after the product is on shelves.

Common Mistakes

Each of these creates real risk during FDA inspections or quality events.

• No quality agreement at all. In our experience, a large share of emerging supplement brands, around 40 percent, operate without a formal quality agreement (Inventory Ready estimate). When a batch fails, there is no documented procedure for resolution.
• Signing the manufacturer's template without changes. A manufacturer's template can assign most of the quality responsibility to the brand and little to the manufacturer. Review every clause.
• Combining quality and commercial terms. When pricing and quality terms share a document, commercial pressure can influence quality decisions. 'We'll accept the out-of-spec batch if you discount the next order' is a compliance failure waiting to happen.
• No change notification requirements. A manufacturer changes an ingredient supplier to save cost. You don't find out until a customer reports the product tastes different. Or worse, until an identity test fails.
• Vague dispute resolution. When a batch fails and both parties disagree on the cause, a quality agreement without clear escalation steps turns a quality event into a legal dispute.

When to Review and Update

A quality agreement is a living document. Review it at least annually and update it when conditions change.

• ✓After any product quality event or customer complaint
• ✓When the manufacturer changes equipment, processes, or key personnel
• ✓When you add new products or change formulations
• ✓After an FDA inspection of either your operation or the manufacturer's facility
• ✓When regulations change (new testing requirements, updated limits)
• ✓Before renewing the manufacturing contract for the next term

For more on cGMP requirements that shape quality agreements, see our Part 111 compliance guide. For evaluating manufacturers before you reach the quality agreement stage, start with the manufacturer evaluation guide.

Concepts Covered