The latest Form 483 – which is the second the contract manufacturing organisation (CMO) has received for the plant - includes three new inspectional observations made by the Food and Drug Administration (FDA) during a seven-day visit to the site earlier this month.
Albany Molecular Research (AMRI) announced it had received the new Form 483 in a press statement published yesterday, describing the new observations as “limited in scope and nature” without providing any additional details.
The Burlington plant has been a problem for AMRI since it acquired it through the takeover of Hyaluron in June 2010 . The difficulties began two months later when the FDA issued a warning letter citing several significant current good manufacturing practices (cGMP) violations at the site.
A subsequent re-inspection of the plant in June 2011 saw the agency issue a Form 483 detailing seven inspectional observations, which AMRI has been working to address through a series of corrective measures implemented over the past two years.
And – leaving aside the new Form 483 – these efforts have worked according to AMRI which said that: “No observations were issued by the FDA following their review of the 2011 Form 483 corrective actions” following the latest inspection.
The CMO added that it is working on a response to the new Form 483 that it will send to the FDA soon.
Until details of the new Form 483 are provided it is difficult to gauge how significant an impact it will have on on AMRI’s remediation efforts. However, the upbeat response of CEO Thomas D’Ambra suggests it may be minor.
"We are pleased to have the FDA inspection of our Burlington operations completed," he said, adding that "I would like to acknowledge and thank the leadership and staff in Burlington for their hard work and dedication to quality, our customers and patient safety.”
D’Ambra reiterated that: “Burlington will continue to operate without restriction while we await the FDA's disposition."