​vALIDATION sERVICES / DEFECT SAMPLE SET FABRICATION

Products in Vials, Ampoules, Syringes and Cartridges. In Practical Aseptic Processing: Fill and Finish ed. Jack Lysfjord (Vol. 1, pp. 275-304). Bethesda, MD:  PDA.

Meet our Director of Operations and President:

Pedro J. Méndez, Sr.
Mr. Méndez has worked in different areas of responsibility in pharmaceutical plants and laboratories. He has directed construction certifications, validations, and quality control projects in Brazil, Mexico, and Argentina to assist his customers in complying with FDA regulations, and has also assisted customers in the U.S. with their validations and regulatory needs. Mr. Méndez’s expertise is in validations, product and technology transfers, manufacturing processes, and business management, in which he has worked for over 34 years. Throughout his carrier, Mr. Méndez has achieved various awards, which includes a Supplier of the Year Award from Johnson & Johnson, State Blue Chip Award by the USA Chamber of Commerce, etc. He holds a B.S. in Chemistry from the University of Puerto Rico. Mr. Méndez also co-wrote the following: 





P.O. BOX 1237, MCKINNEY, TEXAS 75070 / TEL. 972-859-0300 / FAX 214-291-5713

info@atusallc.com

Mendez, P. J., De la Montaigne, M., & Tagaya, R. (2009). Inspection of Parenteral 

ATUSA, LLC is a team of professionals with over 40 years combined experience assisting FDA-regulated companies with full life cycle validation services. Our company has the resources and the experience to develop complete validation packages for process, utility systems, manufacturing, packaging, and inspection equipment, laboratory equipment, and computerized systems. We also provide services for your quality documentation needs.


We work side by side with our customers to reach common business goals and to produce economical results. We are committed to conduct business and to negotiate with our customers, suppliers, and partners in an equal and fair fashion recognizing our mutual interests.

About us