FDA 483 - Ion Labs Inc. - December 06, 2022

Ion Labs Inc., a dietary supplement manufacturer in Largo, FL, was cited for significant quality control deficiencies. The inspection revealed failures in reviewing and approving documentation for product specifications, leading to the release of out-of-specification products due to unreliable analytical test results and calculation errors. Additionally, the firm lacked established sampling plans for obtaining representative samples of finished dietary supplement batches.