FDA EIR - Cispharma Inc. - July 26, 2019

An FDA inspection was conducted at CutisPharma, Inc. in Wilmington, MA, from July 22 to July 26, 2019. This current Good Manufacturing Practice (cGMP) inspection, governed by the Food, Drug, and Cosmetic Act, aimed to assess the firm's adherence to quality and operational standards for drug compounding. The primary violation identified was a lack of cGMP training for a temporary manufacturing operator, a critical gap in personnel qualification noted during the review of employee training records. Despite this, the inspection reported no deficiencies across several other key areas, including manufacturing operations, the quality system, materials management, facility and equipment systems (including cleaning and water systems), packaging and labeling, and laboratory controls. In response, Mr. David Quadros, Vice President of Operations, committed to ensuring that all personnel receive adequate training and are knowledgeable about cGMP requirements, and that all operating procedures are consistently followed to uphold product quality and safety.