|Mylan CEO Heather Bresch|
Mylan's Agila Specialties, which has already had production at three Indian plants affected by an FDA warning letter, stopped manufacturing at its Poland facility last fall after health inspectors there found major issues with the plant's sterile manufacturing areas.
When the FDA issued its warning letter in August, Mylan ($MYL) CEO Heather Bresch said the company was dedicated to quality and was working with the FDA to get problems at Indian plants resolved. What she didn't mention was that a month earlier, Polish authorities had uncovered serious issues with modifications the plant in Warsaw had made in its HVAC system that were hampering pressure and airflow in sterile manufacturing areas.
According to a posting by the European Medicines Agency (EMA), Mylan informed Polish authorities in October that it was suspending production of all products vials, prefilled syringes and ampoules at the Warsaw plant while it dealt with the HVAC concerns. The Poland health authorities on Dec. 9, formalized the situation, issuing a suspension of manufacturing order until the problems all resolved, the EMA filing says.
There were 29 major deficiencies that pose a risk of "microbial and particulate contamination" tabulated by Polish authorities during an inspection of the plant last July. Most of those were related to major modifications Mylan made to the HVAC system in December 2014 but failed to get qualified by authorities. The plant had manufactured 49 batches between then and when inspectors arrived 7 months later to discover problems with pressurization in the sterile manufacturing areas.
In addition, there were problems with "crumbling insulation of pipes, peeling teflon on the ports of tanks and pumps, lack of labelling and mixed clean and dirty equipment," the EMA report says. The authority said it did not issue a product recall for the affected batches.
Air flow was among issues FDA inspectors noted at the three Indian plants cited in the warning letter last year. Mylan bought the sterile injectables business in 2013 from India's Strides Arcolab, now Strides Shasun, for $1.75 billion deal. But even before the deal closed, one of its plants was cited in an FDA warning letter. In fact, the FDA said that warning should have been an indicator to Mylan that the plants' manufacturing processes needed attention.
According to public filings, Mylan in 2014, collected $150 million in contingency fees from Strides to cover a portion of the costs related to fixing the problems at the plant. But in December, Strides acknowledged that Mylan was asking for more. Strides said it still had $200 million in escrow to cover any additional payments if required.
- access the inspection report here