Nutraceuticals

Dietary supplement manufacturers must comply with applicable FDA requirements, including dietary supplement current Good Manufacturing Practice regulations under 21 CFR Part 111. These requirements address areas such as personnel, facilities, equipment, production and process controls, quality control, and records. Other requirements may apply depending on the product and business activities. RCA helps nutraceutical companies assess compliance gaps and strengthen quality systems and manufacturing practices.

Dietary supplement cGMP requirements establish controls intended to ensure supplements are consistently produced and meet applicable quality specifications. Manufacturers should establish appropriate procedures, maintain required records, qualify suppliers, control production processes, and ensure quality control responsibilities are fulfilled. RCA provides compliance consulting to help supplement companies evaluate their practices, identify deficiencies, and develop improvements aligned with applicable FDA requirements.

Dietary supplement companies should review their procedures and records, assess supplier qualification and ingredient controls, verify production documentation, and evaluate whether quality control processes meet applicable requirements. Employees should understand their roles and know how to retrieve accurate records. RCA helps organizations prepare for regulatory inspections through compliance assessments, quality system reviews, and practical remediation support.

Manufacturers can strengthen supplier quality by establishing risk-based qualification procedures, evaluating supplier documentation, verifying ingredient identity, defining material specifications, and maintaining appropriate records. The controls needed depend on the ingredient, supplier risk, and applicable requirements. RCA supports supplier quality management, compliance assessments, and quality system improvements to help supplement companies strengthen oversight of their supply chains.

A dietary supplement company should assess the findings, determine root causes, evaluate the impact on product quality, and implement corrective actions with documented evidence of completion and effectiveness. Depending on the issues, remediation may involve procedures, supplier controls, production records, quality oversight, or employee training. RCA helps organizations assess compliance gaps and develop practical remediation strategies to support sustainable compliance.