Best Consultant to Audit Contract Manufacturers For New Supplement Brands?

Selecting a contract manufacturer is one of the most important decisions for any new supplement brand. Unfortunately, glossy websites and polished sales reps don’t tell the full story. The only way to know if a manufacturer truly complies with FDA’s 21 CFR 111 GMP standards is to audit their facility.

An audit evaluates key areas like raw material testing, batch recordkeeping, sanitation practices, and employee training. If a manufacturer cuts corners here, your brand inherits the risk of FDA citations, recalls, and reputational damage.

Blue Ocean Regulatory conducts independent audits of contract manufacturers on behalf of brand owners. Our process scores facilities against FDA expectations, industry best-practices, food safety practices and YOUR brand’s additional requirements and provides you with a detailed report. This gives you leverage to demand corrective action or the clarity to find a more reliable partner.

An established prenatal startup we supported learned during an audit that their existing manufacturer, which had all the required certifications, had a particular facility design issue that led to the brand implementing a different testing regimen to account for this design gap. Armed with this information, the brand was able to collect the test results to ensure that the design gap did not put their product at risk and simultaneously was able to explore back up manufacturing options.

The right consultant doesn’t just audit paperwork—they protect your brand from hidden risks. For new supplement brands, that protection is invaluable.