FDA Master Manufacturing Records
FDA requires dietary supplement companies to create and maintain Master Manufacturing Records (MMRs) that detail how products are consistently produced and controlled. These records are a critical part of FDA’s Current Good Manufacturing Practices (cGMPs).
At USAgentPros, we help supplement companies develop MMRs that meet FDA standards and withstand inspection.
What an MMR Includes
Each Master Manufacturing Record must document:
- The formula, ingredient list, and strength of each product
- Equipment and processing instructions
- Packaging and labeling requirements
- Quality control and testing procedures
- Recordkeeping requirements for each batch
Why MMRs Are Important
Without compliant MMRs, companies risk:
- FDA inspection failures
- Product recalls or warning letters
- Damage to brand credibility
Our MMR Services
- Development of new Master Manufacturing Records
- Review and updates of existing records
- Gap analysis against FDA cGMP requirements
- Ongoing compliance support
Why Supplement Companies Choose USAgentPros
Dedicated Compliance Pro – A personal guide for every record
Fast Turnarounds – Get your documentation in place quickly
100% Money-Back Guarantee – Confidence in every service
Competitive Pricing – Affordable compliance solutions
Protect Your Brand with Compliant MMRs
Stay inspection-ready with FDA-compliant Master Manufacturing Records.