GUNA’s manufacturing process meet FDA’s highest international standards
21 September 2014
After a thorough and detailed 10 day inspection, the United States Food and Drug Administration (FDA) has confirmed GUNA’s manufacturing facility and processes meet the highest international standards for a pharmaceutical company. This successful FDA inspection was carried out in May 2014 with specific focus on the injectable production lines. It ensures that GUNA’s production processes meet the most stringent requirements set by the FDA and with no significant observations or corrections made by the inspector. GUNA have had an extremely successful inspection – a rare occurrence in the pharmaceutical industry.
GUNA’s 60,000 sq. mt manufacturing facility in Milan, Italy is considered among the most modern pharmaceutical laboratories in the world. The groundbreaking facilities and state of the art technology allow us to produce the most advanced medical treatment concepts and products available today.
“This is a great achievement for GUNA, please join me in the warmest thank you to our colleagues here who worked 24/7 to ensure the success of such inspection” said GUNA’s President Dr Alessandro Pizzoccaro.
As soon as we receive the final report from CDER, GUNA will be the first homeopathic pharma “pre-approved” for the production of sterile liquid products”.