In the framework of the inspection control over certified products in late November 2018, the certification of the fgbi "VGNKI" revealed the following violations in relation to the three certificates of conformity.
On November 27 the certification Body of the fgbi "VGNKI" has decided to suspend the certificate of conformity № POCC RU.CC07.B00176 "Microderm" – Vaccine against dermatophytosis animals alive lyophilized (manufacturer LLC "Pharmacy Service"). This decision was made in connection with the evasion of the holder of the certificate of conformity from passing inspection in accordance with clause 6.3 GOST 31815-2012 "conformity Assessment. The procedure of the inspection control certification procedures".
When conducting vaccine trials "Calmaben" (Vaccine against avian salmonellosis bivalent) obtained a negative result in terms of "иммуногенностьSalmonella Ent.". In this regard, on November 29 the certification of the fgbi "VGNKI" has decided to suspend the certificate of conformity № POCC IL.CC07.B00087 vaccine "Calmaben" issued by ABIC Biological Laboratories Ltd.
Also, the certification of the fgbi "VGNKI" suspended the certificate of conformity № POCC RU.CC07.B00325 the rabies Vaccine inactivated dry culture of strain "Schyolkovo-51" for dogs and cats (Rabican) issued by FKP "Shchelkovo biokombinat". The decision was made due to inconsistencies vaccine samples (two series) with the established quality requirements. Discrepancies established by the Rosselkhoznadzor in the framework of the quality control of medicinal products for veterinary use (26.11.2018 ex. № FS-KS-2/30137, from 28.11.2018 ex. № FS-KS-2/30533).
Translated by service "Yandex.Translation"