FDA Performs Re-inspection of AMRI Burlington MA Facility
News Jul 26, 2013
As previously disclosed, Albany Molecular Research, Inc. has received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA’s inspection of the Company’s pharmaceutical manufacturing facility located in Burlington, Massachusetts.
The Company acquired the facility on June 14, 2010. From June 8, 2011 through June 28, 2011, the FDA conducted a re-inspection of the Company’s Burlington facility.
On June 28, 2011, the FDA issued a Form 483 report to the Company, which included seven inspectional observations (the “2011 Form 483”).
On September 26, 2011, the Company issued a press release announcing the receipt of a letter from the FDA stating that corrective actions proposed by the Company, once fully implemented, should adequately address the observations made by the FDA investigators.
The letter also indicated that the Company’s corrective actions would be verified by the FDA at the next facility inspection.
From July 11, 2013 through July 18, 2013, the FDA conducted a general inspection of the company’s Burlington facility, operations and quality systems, including a systematic review of corrective actions related to the 2011 Form 483.
On July 18, 2013, at the conclusion of the inspection, the Company received a Form 483 having three inspectional observations which are limited in scope and nature (the “2013 Form 483”).
No observations were issued by the FDA following their review of the 2011 Form 483 corrective actions.
The Company is currently preparing a complete response to the FDA’s 2013 Form 483 with all corrective actions addressed and implemented and expects to issue such report to the FDA shortly after which time the FDA may choose to lift the Warning Letter.
The Company is continuing manufacturing operations currently ongoing at the Burlington site, including GMP operations.
“We are pleased to have the FDA inspection of our Burlington operations completed,” said Thomas E. D’Ambra, Ph.D., AMRI’s President and CEO. “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. Burlington will continue to operate without restriction while we await the FDA’s disposition.”
Concept Life Sciences appoints New Group Programme Manager and US Head of SalesNews
Key leadership appointments support integration of the Group and expansion in the US market.READ MORE
Alzheimer’s Drug Discovery Foundation Announces $1.8M in New FundingNews
The Alzheimer’s Drug Discovery Foundation (ADDF) announces nearly $1.8 million in new funding, which reflects a commitment to advancing drugs in or near human clinical trials. All five funded programs are potential treatments for Alzheimer’s disease and other forms of dementia.READ MORE
New Research Hub to Tackle Global Vaccination ChallengesNews
The University of Bristol will contribute to a new research hub to increase global immunisation coverage and improve response to viral outbreaks through the rapid and cost-effective deployment of vaccines.READ MORE