Ion Labs Advised of GMP Violations

WASHINGTON FDA recently sent a warning letter to Clearwater, Fl.-based Ion Labs due to failure to respond sufficiently to a prior 483 observation report given to the company after FDA inspected its facility. Among the key deficiencies noted in the report and letter are problems with the way the company reprocessed materials and failed to meet specifications for purity and strength. FDA gave the company 15 days to respond with details on the specific steps taken to correct these deficiencies.

FDA inspectors noted the company failed to verify its finished batch of supplements met the specifications for purity and strength. FDA determined assay data provided by the company was insufficient, as it did not provide quantitative data to determine if the specifications for the finished products were met.

Inspectors further noted the company reprocessed dietary supplements that failed quality checks, but did not have documentation proving quality control personnel conducted a material review and made a disposition decision that is based on a scientifically valid reason and approved the reprocessing. Both Slim System and Ion Kidney Flush tablets were cited as having undergone this faulty reprocessing procedure.

In addition to the reprocessing, the company was also cited for failure to establish specs for identity and limits of potential adulterants, as well as for not having complete batch records for production and batch control. The company also "failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting reference materials used in performing tests and examination."