FDA 483 - The Mentholatum Company - March 23, 2026

The Mentholatum Company in Orchard Park, NY, received a Form 483 with four observations following an FDA inspection. The firm demonstrated significant deficiencies in its out-of-specification (OOS) investigation practices, often failing to determine root causes and releasing products based on retest results without proper justification. Additionally, issues were noted in laboratory record-keeping, the unscientific alteration of batch release specifications, and inadequate Annual Product Review procedures, indicating systemic quality control failures.