FDA 483 - The Mentholatum Company - June 17, 2021

An FDA inspection of The Mentholatum Company in Orchard Park, NY, from June 15-17, 2021, revealed significant deficiencies in manufacturing practices. Observations included failures to follow written procedures for raw material testing, inadequate cleaning and maintenance of equipment, and plumbing defects posing contamination risks. Additionally, the firm was cited for a repeat deficiency regarding the delayed submission of an adverse event report for a nonprescription drug.