Fines will not deter soulless executives
The Nov. 2 editorial, “Failure to regulate,” persuaded me to address the referenced issue. My three decades of critical pharmaceutical parenteral drug manufacturing occurred at state-of-the-art facilities with well-trained, trustworthy employees located on Grand Island.
We were inspected intensely and frequently by the Buffalo U.S. Food and Drug Administration District Office to assure no violations were present. The inspections were unannounced. The FDA was involved because our pharmaceutical products were shipped interstate and worldwide. Additionally, customs also inspected our facilities.
The firm responsible for the apparent unbelievable criminal activities noted in the editorial obviously distributed adulterated products in interstate commerce without competent regulatory surveillance. Thus, the deadly outbreaks of fungal meningitis illness and its catastrophic consequences.
The injection of parenteral products into the blood vessels mandates products are manufactured with utmost care and in an aseptic environment to avoid contamination resulting in tragic events.
In an effort to assure we always distributed safe and effective products, we created an independent professional quality assurance department reporting directly to upper management, avoiding bias in releasing products.
In a diminutive summary, our consumers are defenseless patients who entrust their wellbeing to our industry. It is our moral responsibility never to violate that trust. Fines do not deter soulless executives from distributing catastrophic products. These are knowing felons who must be prosecuted finally for supplying poison no less than street purveyors.
Richard E. Greco Sr.
Founder, Regulatory Affairs
Professionals Society, Clarence