FDA 483 - Betco Corporation, Ltd - April 17, 2025

The FDA inspected Betco Corporation, Ltd in Bowling Green, OH, an OTC drug manufacturer, and issued a Form 483 with four observations. The inspection revealed significant deficiencies in component identity testing, inadequate water system qualification and maintenance, and insufficient laboratory sampling plans for water. Additionally, the quality control unit lacked written procedures for Out-of-Specification (OOS) investigations, leading to untracked instances.