Regulators Find Deficiences at Agila's Poland Plant, Suspend Manufacturing

Source: RAPS

Jan 20, 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

Read the RAPS coverage