Mylan: GMP issues and production halt at Agila aseptic plant 'not material'

By Dan Stanton

- Last updated on GMT

Image: iStock/selensergen
Image: iStock/selensergen
Mylan has stopped production at a sterile injectables plant after Polish regulators observed 29 major violations of GMP, an EU statement of non-compliance reveals.

An inspection of the facility in Warsaw was carried out by Poland’s pharmaceutical regulation body (GIF) in July last year.

According to the statement of non-compliance​ published on the EudraGMP database yesterday (and embedded below), “major deficiencies were found in Agila Specialties which pose a risk of microbial and particulate contamination and could not assure the sterility of the final product.

These were mostly related to the design and qualification of HVAC (heating, ventilating, and air conditioning), cleaning and maintenance of clean areas, manufacturing and batch releasing, and change control.

In October, Mylan implemented a voluntary suspension of production at the plant “of all products related to the modification and qualification of the HVAC system,”​ though this was formalised in December when GIF issued a decision to suspend manufacturing activities until the removal of non-compliances at the site.

The facility became part of Mylan’s manufacturing network (along with eight other plants) when the company acquired Agila Specialities from Strides Arcolab for $1.6bn (€1.5bn) in 2013​.

At the time, Mylan said the global injectable shortage – caused in part by quality issues at a number of large aseptic plants​ – was a key driver in the acquisition. The site makes vials, ampoules, pre-filled syringes and lyophilized injections.

Mylan spokesperson Nina Devlin said the impact of the production halt and regulatory statement is "not material"​ but offered no further comments to in-Pharmatechnologist about potential shortages or remediation plans.

Agila compliance issues

This latest news is not the first Agila-related headache for Mylan.

In 2014, Mylan issued a voluntary recall​ of 10 lots of the anaesthetic agent Etomidate - made at the plant on behalf of Pfizer - after small black particles, identified as paper shipper labels, were discovered in vials.

And last year​ foreign particulate matter was discovered in test samples, leading to recalls of chemotherapy treatments made across the Agila network, including at a site in Bangalore hit by a US Warning Letter in 2013​.

The same facility was cited in a second Warning Letter​ issued last year, which also indicted a second former-Strides Agila Indian plant.

In September​, Mylan’s CEO Heather Bresch said the firm was on-track with remediation plans across its Agila network.

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