FDA 483 - CerBurg Products Ltd. - September 17, 2021

Cerburg Products Ltd. in South Daytona, FL, an own label distributor of ProFibe dietary supplement, was cited for significant deficiencies in its quality control operations. The inspection revealed a lack of written procedures for critical processes such as material review, disposition decisions, and product complaint investigations. Additionally, the firm failed to verify finished product specifications and provide stability data to support product expiration dates, with some issues being repeat observations from a previous inspection.