Melissa T Roy takes a procedural and systematic approach to inspections. She scrutinizes all facets of the manufacturing process, with a heavy focus on the role of the quality control unit, adherence to established rules and protocols, and the cleanliness status of equipment. She closely reviews the record-keeping process and expects a high level of compliance with written procedures.

Melissa T Roy is an FDA inspector who is thorough, detail-oriented, and expects a high standard of compliance from manufacturers. Her primary focus areas revolve around the systematic process control, quality unit oversight, change management, and cleanliness and sanitization of equipment. She places a significant emphasis on adhering to written procedures and demands detailed and reliable record keeping.