FDA 483 - Woodbine Products Company - February 13, 2026

Woodbine Products Company Inc. in Medina, OH, received a Form 483 with six observations following an FDA inspection from February 9-13, 2026. The inspection revealed significant deficiencies across multiple areas, including inadequate component identity testing, premature release of finished drug products, and a lack of essential written procedures for quality control and process validation. These findings indicate a systemic failure to ensure the quality, purity, and strength of their OTC drug products.