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CTK OTC Laboratories LLC (formerly FMK LABS, Inc.) was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs. During a December 2024 inspection, the FDA found that the company failed to adequately investigate out-of-specification (OOS) results, including a bulk base batch with low potency that was corrected through re-mixing and API addition without determining the root cause, and subsequently experienced high viscosity issues that were not properly investigated. These manufacturing deficiencies rendered the drug products adulterated under federal law, as the company's methods, facilities, and controls did not conform to CGMP regulations.