Regulators Find Deficiences at Agila's Poland Plant, Suspend Manufacturing
20 Jan 2016
Poland’s Main Pharmaceutical Inspectorate has hit Mylan subsidiary Agila Specialties with a statement of GMP non-compliance following an inspection of the drugmaker's Warsaw-based manufacturing site.
Regulators noted 29 major deficiencies that put products at risk for microbial and particulate contamination, mostly sourounding the HVAC system and cleaning and maintenance.
Polish regulators have suspended manufacturing activities from the warsaw site as of December 9, 2015.
In February 2014
Agila initiated a recall
of an injectable general anesthesia due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials
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