US FDA lifts its warning letter related to the plant
AMRI has received a close-out letter from the US Food and Drug Administration (FDA) lifting a 2010 warning letter related to its Burlington, Massachusetts aseptic fill-and-finish facility.The US firm took over the plant in June 2010 when it acquired Hyaluron, and the FDA issued a warning letter just two months later, citing the company for its injectable drug contamination.
After a re-inspection in June 2011, the Agency issued a Form 483 detailing seven problems in need of correction, and AMRI said it has since rectified those issues.
The FDA confirmed AMRI's work in July this year and issued another Form 483 containing three observations that were 'limited in scope and nature,' according to the company.
AMRI then prepared a response letter detailing its corrective actions, aiming to convince the FDA to lift its warning letter, which has now happened.
We remain committed to maintaining our uncompromising focus on quality, culture and performance at Burlington
Thomas D’Ambra, AMRI's President and CEO, said: 'AMRI is pleased to report that we have resolved all issues raised by the FDA related to our Burlington, Massachusetts facility. This is consistent with feedback we have received from numerous customer quality audits of our Burlington site, confirming that the corrective actions, improvements and upgrades taken at this facility provide even stronger support for our growing customer list and meet the high standards necessary to successfully operate an injectable dosage form operation.
He added: 'I would like to acknowledge and thank the many AMRI colleagues who have worked tirelessly and diligently to achieve this important milestone.
'Moving forward, we remain committed to maintaining our uncompromising focus on quality, culture and performance at Burlington and all of our locations worldwide.'
The Burlington facility is an established provider of cGMP manufacturing and sterile filling of parenteral drugs using specialised technologies, including lyophilisation and 'Bubble-free filling', a unique patented technology.
With its cGMP aseptic formulation and filling expertise, AMRI Burlington supports pre-clinical to commercial scale production of liquid-filled and lyophilised parenterals. These services are provided for both small molecule drug products as well as biologicals.
In June this year, AMRI Burlington received an expanded registration to handle Schedule II and IIN controlled substances. This allowed the plant to offer filling services for Schedule II, IIN, III, IIIN, IV, and V controlled substances, as well as offer services to complement more AMRI Rensselaer projects in New York State.