FDA Performs Re-inspection of AMRI Burlington MA Facility
ALBANY, New York, July 22, 2013
ALBANY, New York, July 22, 2013 /PRNewswire/ --As previously disclosed,
Albany Molecular Research, Inc. ("AMRI" or "the "Company") (NASDAQ: AMRI)
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").
(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO )
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
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
About AMRI Albany Molecular Research, Inc. (AMRI) is a global contract
research and manufacturing organization offering customers fully integrated
drug discovery, development, and manufacturing services. For over 21 years
AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology
industries have undergone tremendous change in response to multiple
challenges. This experience, a track record of success and locations in the
United States, Europe and Asia now provides our customers with SMARTSOURCING™,
a full range of value-added opportunities providing customers informed
decision-making, enhanced efficiency and more successful outcomes at all
stages of the pipeline. AMRI has also successfully partnered R&D programs and
is actively seeking to out-license its remaining programs for further
development. For more information about AMRI, please visit our website at
www.amriglobal.com or follow us on Twitter ( @amriglobal ).
AMRI Forward-Looking Statement Statements in this press release that are not
historical facts are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. These statements may be identified by forward-looking words
such as "may," "could," "should," "would," "will," "intend," "expect,"
"anticipate," "believe" and "continue" or similar words. Readers should not
place undue reliance on our forward-looking statements. The Company's actual
results may differ materially from such forward-looking statements as a result
of numerous factors, some of which the Company may not be able to predict and
may not be within the Company's control. Factors that could cause such
differences include, but are not limited to (a) the results of further FDA
inspections; and (b) the Company's ability to effectively complete the
corrective actions and (c) the timing by the FDA of their further
consideration of the lifting of the warning letter, which is out of the
Company's control, as well as those factors discussed in the Company's Annual
Report on Form 10-K for the year ended December 31, 2012 as filed with the
Securities and Exchange Commission on March 18, 2013 and the Company's other
SEC filings. The Company does not undertake any duty to and does not intend to
update any forward-looking statements contained in this press release after
the date of this press release.
Contact: Investor - Michael Nolan, Chief Financial Officer, +1-518-512-2261,
Media - Gina Monari, AMRI Communications, +1-518-512-2512
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