FDA regulations establishing minimum standards for the manufacturing, processing, and storage of food, drugs, and dietary supplements.
cGMP (Current Good Manufacturing Practice) regulations are enforced by the FDA under 21 CFR (Code of Federal Regulations) and establish minimum standards for facilities, equipment, personnel, processes, and documentation in the manufacturing, processing, packaging, and storage of food, pharmaceuticals, dietary supplements, and cosmetics.
For dietary supplement brands working with 3PLs, the relevant regulation is 21 CFR Part 111, which covers supplement-specific GMP requirements for warehousing and distribution. A cGMP-compliant 3PL must maintain documented procedures for pest control, facility cleaning, temperature/humidity controls, personnel hygiene, lot tracking, and complaint handling.
Non-compliance with cGMP at your 3PL can have serious consequences: FDA Warning Letters, product recalls, and in severe cases, consent decrees that shut down the facility. Always ask supplement and food 3PLs for their most recent third-party audit results (SQF, NSF, or AIB certification) and their FDA inspection history.
Ask for their FDA facility registration number, most recent third-party audit certificate (SQF, NSF, or AIB), and their last FDA inspection report. Review the audit findings — minor observations are normal; repeat major findings or warning letters are red flags. Also ask to tour the facility before signing.
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