Announced yesterday, the US Food and Drug Administration’s (FDA) letter lifted over three years of woe at the plant stemming from an original Warning Letter AMRI received in August 2010 highlighting a number of violations in sterile manufacturing.
In a video posted on YouTube yesterday, Senior Director of the Burlington site, Christian Phillips, said “the lifting of the warning letter is a pivotal milestone” for the site.
He continued: “The whole remarkable story of the remediation really speaks and is a testament to our brand at AMRI and the fact that persistence and endurance and steadfast focus ultimately leads to successful outcomes.
“I’m just proud in a day and age where many firms out there - both CMOs and innovators alike - where they continue to struggle with quality issues in an industry that continues to have issues with critical drug shortages, that we have really emerged and been identified as part of the solution.”
The sterile injectable site was acquired for $27m (€22m) from Hyaluron in 2010 just weeks before the Warning Letter was received.
Louis Garguilo, VP of Business Development and Head of Marketing Communications told Outsourcing-Pharma.com, “the site has been fully operational since the second quarter of 2011” and “the Warning Letter did not preclude us from working on customer projects.”
Furthermore, though he added AMRI maintained its client relationships during the regulatory scrutiny and also - counter to analyst predictions -saw a number of new customers. “Moving forward we hope for even more projects from both existing and new customers,” he said.
Though an inspection at the facility resulted in a Form 483 earlier this year, the observations were not related to the original Warning letter and Garguilo said the firm “expects to receive the EIR from the July 2013 inspection shortly.”
Remediation to FDA’s Enhanced Standard
Due to a combination of revenue impairment from regulatory holdups and the cost of remediation, the plant was infamously labelled “a money-pit” at the time by Jeffries’ analyst David Windley.
Speaking with this publication at this year’s Interphex in New York, Phillips said following the Warning Letter, AMRI had “immediately embarked upon this holistic and very comprehensive remediation effort across our quality systems, across the culture of the site.”
“We shut down voluntarily operations at the site for about 8 months,” he added. “We revised all facets of our quality system and embarked upon a number of continuous improvement initiatives to enhance the facility infrastructure.”
Phillips also spoke of the “new bar” in FDA enforcement activity that began in 2009 when current FDA Commissioner Margaret Hamburg tookover.
“It turned out to be a really remarkable and rewarding story because this site was hit with that warning letter early on, right after [the FDA’s] enforcement initiative took place,” he said, allowing AMRI to pass “that value and lessons learned” onto its clients.