SUKL – the Czech State Institute for Drug Control – raised concerns about the facility in a post on the EudraGMDP database that also gave details of an inspection conducted on Tuesday.
The Agency wrote “From the knowledge gained during inspection…it is considered that it does not comply with the GDP requirements referred to in the Commission Guidelines on Good Distribution Practice of medicinal products for human use laid down in Article 84 of Directive 2001/83/EC.”
SUKL spokeswoman Hana Pavlíčková confirmed the findings, telling us the non-compliance was related to the “distribution of medicines from premises that are not listed in the WDA [Wholesale Distributor Authorisation].”
She went on to say that a “prohibition of supply and holding of medicines in unapproved storage facilities has been issued,” adding that SUKL has also ordered B.Braun to “transfer of medicines into approved storage space.”
Pavlíčková also said: “The inspection has not been completed yet, therefore we are not able to estimate further developments or a time frame.”
B.Braun Medical – a subsidiary of German medical products supplier B. Braun Melsungen AG – was issued with a WDA (24168/1/INS/00) for the warehouse in 2000.