Loading…
Tower Laboratories Ltd. manufactured over-the-counter drug products in violation of Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated. FDA investigators found that the company failed to thoroughly investigate out-of-specification (OOS) laboratory results from October 2024 to June 2025, including failed assay testing on tablet lots at the 9-month stability timepoint, and did not implement adequate corrective and preventive actions (CAPA) or notify customers of the failing results. The inspection of the Montague, Michigan facility from July 8-11, 2025 identified deficiencies in batch investigation procedures under 21 CFR 211.192, with laboratory investigations lacking sufficient detail and root cause analysis.