Official statement of VUAB Pharma a.s. to the Warning letter issued by the U.S. FDA regarding the active substance Nystatin and its audit.
VUAB Pharma herewith declare to operate fully in terms of cGMP, i.e. Good manufacturing practice.
Quality of Nystatin –API is of high-grade, the results of the control measurements show much lower parameters than binding international limits prescribed by the European, British and the U.S. Pharmacopoeia.
VUAB Pharma is regularly inspected by the state authorities (State Institute for Drug Control, FDA) and audited by our customers and various independent international auditing companies.
“We believe that the current issue is a misunderstanding. Our company was inspected by the U.S. FDA several times in the past, in the year 2011 without notice” said Jan Mengler, CEO of VUAB Pharma. During the inspection of Nystatin-API in June 2014, the FDA identified deficiencies, which can occur in the field of pharmacy.
Based on this fact, VUAB Pharma took both immediate and systemic corrective actions to eliminate these deficiencies. In July and December 2014 our company forwarded to the FDA very detailed reports of all corrective actions implemented.
In May 2015, the company VUAB Pharma received from the FDA the notification that the listed actions are insufficient.
“We are surprised by this FDA´s letter, but nevertheless the letter in no case means the loss of the certification for the U.S. market, our production continues fully standard further. From the FDA´s side it is completely usual procedure and not final decision of the audit at all ” explained Jan Mengler and added that “Currently the whole matter is being discussed by our attorneys in the U.S. with the Center for Drug Evaluation and Research FDA. We firmly believe in the satisfactory resolution of the situation in the near future. “back