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

An FDA inspection of CerBurg Products Ltd., a dietary supplement own label distributor, was conducted from September 15-17, 2021. The inspection assessed the firm's compliance with the dietary supplement current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 111. The inspection revealed significant deficiencies, many of which were repeat or similar observations from a previous inspection in 2017. Key violations included the absence of written procedures for quality control operations, such as material review, disposition decisions, and approval of reprocessing. Furthermore, CerBurg Products Ltd. failed to ensure finished batches conformed to all established product specifications, relying solely on microbiological testing rather than verifying identity, purity, strength, and composition before product release. The company also lacked stability testing data to substantiate the 3-year expiration date assigned to its ProFibe dietary supplement and did not have written procedures for reviewing and investigating product complaints. Management acknowledged the observations and committed to making corrections. The FDA emphasized the importance of compliance with the Federal Food, Drug, and Cosmetic Act and requested an adequate written response to the Form FDA 483 within 15 business days to influence potential further agency actions. Notably, the firm indicated it would be permanently closing at the end of 2021.