In November 2013, the US Food and Drug Administration issued a warning letter to the site in Spokane, Washington after an inspection found the drug and ingredient maker had committed a number of cGMP violations including the “failure to assure an adequate system for cleaning and disinfecting aseptic processing areas and equipment.”
But in a letter filed Friday with the Bombay Stock Exchange, the contract manufacturing organisation’s (CMO) parent company Jubilant Life Sciences said the regulatory agency has upgraded the plant from the status of Official Action Indicated (OAI) to Voluntary Action Indicated (VAI).
“Jubilant remains committed to continuous improvements to maintain compliance at all its pharmaceutical manufacturing facilities across the globe,” said Jubilant’s Chairman Shyam Bhartia and Co-Chairman Hari Bhartia in a joint statement.
“We consider this development as another step towards building a reliable and sustainable pharmaceutical business.”
The Spokane site consists of two manufacturing complexes offering customers aseptic filling and lyophilisation, producing batch sizes from 20 to 3,000L.
Other violations cited in the 2013 letter were the presence of unknown impurities in a finished product which led to a voluntary recall, and issues with the firm’s lack of provisions “for adequate impact evaluation of significant maintenance shutdowns.”
The firm also has a sterile filling and lyophilisation site in Montreal, Canada which was hit with a warning letter in February 2013 after FDA inspectors observed water running on the floor between the equipment wash room and the corridor leading to the vial filling area. A close-out letter was issued in September 2014.