Dietary Supplement cGMP auditing

Dietary Supplement cGMP Services

For Dietary Supplement Manufacturing inspections, section 21 CFR part 111 must comply with cGMP regulations for manufacturing, packaging, labeling or holding operations for Dietary Supplements.
Firms must register with the FDA even though they do not have to receive approval from FDA prior to manufacturing and selling dietary supplements.
Manufacturers and distributors also must make sure labeling claims and information are not misleading and truthful and do not risk claims of unapproved new drugs.
The following subsystems are auditied for compliance with part 111 include the following per FDA’s website link.