Supplement Firm Fails GMP Inspection Four Months After Third-Party Certification
GMP warning to Nutra Solutions USA reflects not only that manufacturers and other supplement firms are responsible to maintain compliance at their facilities, but also third-party inspectors should be responsible for their certifications, say industry stakeholders.
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FDA’s GMP final rule set uniform standards to ensure quality throughout manufacturing, packaging, labeling and holding of supplements, but Supplement Safety and Compliance Initiative says manufacturing practices continue to vary widely across the industry and the agency cannot inspect every facility. “FDA can’t solve all our problems. I don’t know if FDA knows the number of facilities it needs to inspect to ensure consumer confidence," says Daniel Fabricant, president of SSCI member NPA.
FDA's first warning letter concerning dietary supplement good manufacturing practices advises Coats International Holdings to follow written procedures, improve documentation and conduct appropriate identity tests