How to choose a contract manufacturer: a 12-point checklist.

Picking a contract manufacturer is the decision that shapes your next three years: cost of goods, launch dates, and what an FDA investigator finds if they visit. Most brands choose on quote and minimum order quantity. The checklist below is what to check before price, from someone who has hosted FDA inspections and qualified suppliers inside a Fortune 500 consumer products company.

The 12-point checklist

1. Confirm FDA registration for your product type.OTC drugs need a registered drug establishment, with your products listed. Cosmetics now need facility registration and product listing under the Modernization of Cosmetics Regulation Act (MoCRA). Ask for the registration numbers and check them yourself.
2. Read their public inspection history.Search the FDA Data Dashboard, warning letters and recall enterprise reports by firm name. A Form 483 is not disqualifying; an unanswered or repeated one is. Ask them to walk you through their last inspection and their response.
3. Ask how they make and monitor water.For aqueous products, water is usually the largest ingredient and the most common source of microbial trouble. Ask for the water system design, sampling plan, alert and action limits, and the last 12 months of trend data.
4. Look at investigations, not just SOPs.Ask for two closed deviations and one out-of-specification investigation (redacted is fine). If root cause says “operator error” and the fix is “retrained”, expect the same failure again.
5. Check lab capability and who releases product.Which tests are in-house, which go to contract labs, and how long release takes. Micro testing turnaround often sets your real lead time.
6. Get a quality agreement before the first PO.FDA’s guidance on contract manufacturing arrangements is clear that the brand owner stays responsible for quality. The agreement should name who approves changes, handles complaints, runs investigations and decides release.
7. Test the change control.Ask what happens if they switch a raw material supplier or a packaging component. You want to be told before, not after.
8. Map their critical suppliers.Ask which of your raw materials and components are single-sourced and what the backup plan is. Supplier continuity is where launch dates quietly slip.
9. Ask for real capacity, not nameplate.Which line will run your product, its current utilization, and changeover time. A plant at 90% loading will schedule you last.
10. Price the whole landed cost.Minimums, tooling, testing, stability, scrap allowances, storage and freight. The cheapest unit price is often not the cheapest product.
11. Plan the tech transfer.Who writes the master batch record, how many engineering and validation batches, and what stability data you need before launch. Agree the timeline in writing.
12. Visit, and talk to the floor.A two-hour audit with the quality lead tells you about the system. Ten minutes with an operator tells you whether it is followed.

Red flags

• They can’t show you water trend data or recent investigations.
• No quality agreement template, or reluctance to sign one.
• A recent warning letter or recall with no clear corrective action story.
• Quotes that skip testing, stability or validation batches.

When to bring in help

If you are choosing between finalists, transferring a product, or a launch depends on a manufacturer you have not audited, an independent operator’s review is cheap insurance. Book a 30-minute clarity call and Kobe will tell you what he would check first. If you run the plant yourself, the same list is what your customers should be asking you: see help for contract manufacturers and OTC manufacturers.

References: FDA, “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (guidance for industry, 2016); Modernization of Cosmetics Regulation Act of 2022; 21 CFR Parts 210 and 211. Recall and Form 483 counts from Claraxis FDA Watch, 12 months to October 11, 2026. This article is general guidance, not legal or regulatory advice.