FDA 483 - Hill Dermaceuticals, Inc. - August 11, 2021

Hill Dermaceuticals, Inc. in Sanford, FL, a drug manufacturer, was inspected and received a Form 483 with four observations. The inspection revealed significant issues with facility maintenance, including peeling paint and holes, a lack of hot water in restrooms, and critical failures in microbiological testing for raw materials and finished products. Additionally, the firm failed to follow written production procedures, specifically regarding personnel hygiene during manufacturing.