Pharmaceutical Facility Completes FDA Inspection with Zero Observations

In late 2014, AM Cleanroom Build and Performance completed a cleanroom construction project for a pharmaceutical laboratory that specializes in high risk compounding. The overall company operation is growing across the US. This facility, located in Texas, was expanded to a larger location to provide better customer experience.

The Texas facility completed its first FDA inspection and it resulted in zero observations.

“This client has a strong commitment to quality throughout all aspects of their business. That approach made it possible for us to design and build a cleanroom facility that adheres to industry standards and passes rigorous inspections so the facility can operate efficiently,” says Robert Logston, Cleanroom Construction Project Executive.

“Not spending time and resources correcting issues means they can stay in full production and streamline their operations and customer experience,” finishes Logston.

The purpose of the inspection was to assure the standards of compliance of the firm’s operations with current Good Manufacturing Practices (cGMPs). The four-day FDA inspection was completed on March 4, 2015 and the final report was issued in May, reconfirming that there were no observations made during the entire inspection process. The inspection was thorough and covered the firm’s Quality, Packaging and Labeling, Production and Facilities and Equipment systems.