Benjamin Misumi Email & Phone Number

Irving, Texas, United States

- Member of the Executive Leadership Team, driving the development of a quality culture aligned with FDA regulations and cGMP- Partner with company leadership to identify strategies and solutions for quality initiatives, process excellence, and scalable growth- Implement policies, processes, and training improvements to support quality initiatives and monitor Key Performance Indicators- Manage Manufacturing/Product Quality Issues, Corrective and Preventative Actions (CAPA), and lead internal and external quality audit activities- Lead client regulatory agency and certification audits, including FDA, GMP, Informed Choice/Informed - Sports, Organic (Texas Department of Agriculture), Texas Department of Health, and international compliance- Provide leadership for quality and regulatory systems based on CFR 21 FDA regulations and cGMPs- Create and maintain SOPs, batch production records, handle complaints, adverse event reporting, and recall handling- Determine required investigations and corrective actions, track and report quality/regulatory information to management- Maintain regulatory files, documentation, HACCP Program, and Food Defense Program

Dallas/Fort Worth Area

Misumi & Windlow, LLC specializes in regulatory compliance, auditing, and cGMP development for FDA-regulated food, beverage, cosmeceutical, and supplement industries. Services include:- Creating, refining, and implementing Quality Management Systems, Standard Operating Procedures, and Good Manufacturing Processes- Assisting manufacturers, brands, and distributors in obtaining certifications such as GMP, NSF, NPA, Organic, and meeting international compliance standards- FDA Regulatory Consulting, Submission, and Auditing Services- USDA/Organic certification and compliance- FSMA Consulting and implementation- Food/Beverage Facility Registration and Auditing Services- Label Compliance-International Compliance

Allen, Tx

- Created and maintained company SOPs, batch production records, and master manufacturing records- Provided leadership for quality and regulatory systems based on CFR 21 FDA regulations and cGMPs- Handled complaints, adverse events, and recall handling; determined required investigations and corrective actions- Tracked and reported quality/regulatory information to management; maintained regulatory files, documentation, HACCP Program, and Food Defense Program- Assured proper raw material procurement, developed and maintained Certificates of Analysis (COAs) and production specifications for finished products- Led client and regulatory agency audits (FDA, GMP, USDA, etc.)- Reviewed labeling proofs for compliance, interpreted regulations, and provided consultancy for compliance needs- Reviewed testing and production records, conducted in-process testing- Interfaced with customers, auditors, and others as necessary for quality and regulatory program requirements- Conducted employee training in areas of responsibility, including GMPs

Carrollton, Tx

- Established and maintained a quality and environmental system consistent with cGMP standards and customer-specific requirements as Management Representative- Evaluated quality system performance, reviewed goal progress, and ensured compliance of processes, products, materials, and components- Maintained, updated, reviewed, and approved quality documentation and SOPs to reflect current processes- Resolved customer complaints and non-conformances to ensure uninterrupted product flow to customers- Managed QC department projects, work flow, and communication; created efficiencies and improved timelines- Assisted with customer complaint resolutions, maintained regulatory files, documentation, HACCP Program, and Food Defense Program- Developed new products, supplement facts panels, and maintained production specifications and Certificates of Analysis (COAs)- Led client and regulatory agency audits, including FDA, CVS, Texas Health Department, and GMP Certification- Reviewed labeling proofs for compliance, interpreted regulations, and provided consultancy for compliance needs- Conducted employee training in areas of responsibility, including GMPs

Coppell Tx

- Provided support and guidance for QA labs and production areas, assisted with Quality and Sanitation processes- Performed internal and external Micro, Chemistry, and Basic laboratory testing on raw ingredients and finished products to ensure compliance with company and customer specifications- Set and communicated daily goals to quality technicians, recorded sanitation and inspection results- Conducted audits, material safety, and other sanitation projects as required by management- Collaborated with the Director of Quality in writing Standard Operating Procedures (SOPs) and Good Manufacturing Processes (GMPs) for the Quality department- Operated, calibrated, troubleshot, and repaired lab equipment, weighing scales, and other production equipment- Acquired knowledge of all technical work throughout the plant- Managed assembly lines with five to fifteen production workers