Ion Labs Inc. – FDA Warning Letter, Jun 3, 2011

On December 5, 2011, the FDA issued a Warning Letter to Ion Labs, Inc. following an inspection from April 19 to June 3, 2011, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the firm's products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to verify finished product specifications:** The firm did not adequately test finished batches for purity and strength, and provided insufficient assay data. 2. **Inadequate laboratory control processes:** Lack of established criteria for selecting non-compendia reference materials used in testing. 3. **Improper reprocessing procedures:** Reprocessed dietary supplements without documented quality control material review, disposition decisions, and approval. 4. **Incomplete batch production records:** Batch records lacked essential information, such as tablet coating processes. 5. **Failure to establish component specifications:** The firm did not establish identity, purity, strength, and composition specifications for raw materials. 6. **Lack of material review for deviations:** No documented material review and disposition decisions for batches deviating from Master Manufacturing Records (MMRs). 7. **Release of out-of-specification products:** Quality control personnel approved the release of finished products that failed established specifications (e.g