21 CFR Part 111 is the FDA's Current Good Manufacturing Practice (cGMP) regulation for dietary supplements, establishing minimum requirements for manufacturing, packaging, labeling, and holding operations in the United States.
Key Compliance Areas:
- 1Component Testing & Identity Verification — — Every raw material must be tested for identity, purity, strength, and composition before use in production. This includes supplier qualification, certificate of analysis (CoA) verification, and independent laboratory testing.
- 1Master Manufacturing Records (MMR) — — Detailed documents specifying each step of the manufacturing process, including ingredient amounts, processing instructions, packaging requirements, and quality control checkpoints.
- 1Batch Production Records (BPR) — — Complete documentation of each production batch, including actual quantities used, equipment used, in-process testing results, and any deviations from the MMR.
- 1Quality Control Procedures — — Written procedures for each production step, including specifications for acceptance or rejection of components, in-process materials, and finished products.
- 1Finished Product Testing — — Every batch must be tested for identity, purity, strength, and composition before release. This includes microbiological testing, heavy metal screening, and potency verification.
Consequences of Non-Compliance
- FDA warning letters (publicly posted on FDA website)
Dovita Nutrition Health LLC maintains full 21 CFR Part 111 compliance at our U.S. facility, with annual third-party cGMP audits achieving zero deficiency ratings for three consecutive years. We provide complete documentation packages to our OEM partners including CoA, batch records, and facility audit reports.
