Multiple violations cause production halt at Mylan-owned Agila's Polish plant
- Mylan has stopped production at a Polish facility operated by its Agila Therapeutics division, a regulatory filing posted on the EudraGMP database revealed Tuesday.
- The Polish regulator, GIF, found 29 major good-manufacturing practices (GMP) violations during inspections conducted in July 2015.
- Mylan informed GIF back in October of its decision to suspend production, although this only came to light with the posting of the regulatory filing.
The Polish Main Pharmaceutical Inspectorate (GIF) found 29 GMP violations in its July inspection, ranging from HVAC particulate contamination to maintenance of sanitary conditions. In one designated clean area, inspectors discovered "crumbling insulation of pipes, peeling teflon on the ports of tanks and pumps, lack of labeling and mixed clean and dirty equipment."
GIF made Mylan's production suspension official in December, and declared manufacturing activities could not resume until the compliance issues were resolved. As of the filing of the notice, all corrective actions have not yet been taken.
Mylan bought Agila Therapeutics from Strides Aroclab in a $1.6 billion deal which closed in December of 2013. At the time, Mylan highlighted how the addition of Agila would boost Mylan's generic injectables business. The acquisition gave Mylan nine manufacturing facilities in India, Brazil, and the aforementioned Poland.
Agila has run into GMP problems before. Last year, the FDA sent a warning letter to two Agila plants in India, in addition to previously flagging GMP issues at an Agila site back in 2013.
In a recent analysis, BioPharma Dive found the FDA had issued 12 GMP-related warning letters to 11 different India-based facilities in 2015, underscoring renewed concerns over API manufacturing quality abroad.
- In-Pharmatechnologist Mylan: GMP issues and production halt at Agila aseptic plant 'not material'
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