UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 28, 2011
ALBANY MOLECULAR RESEARCH, INC.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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000-25323
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14-1742717
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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21 Corporate Circle, P.O. Box 15098, Albany, NY
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12212
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (518) 512-2000
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below) :
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
As previously disclosed, Albany Molecular Research, Inc. (the "Company") 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. The Company has been working to resolve the issues identified in the warning letter and has provided the FDA with interim updates as well as its final update in May, 2011.
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 7 inspectional observations. The Company is currently preparing a response to the FDA’s Form 483 report. The Company will continue the manufacturing operations currently ongoing at the Burlington site, including GMP operations. However, there can be no assurance that the FDA will be satisfied with the Company’s response. The failure to promptly correct any violations as required by the FDA may result in legal action without further notice.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: July 1, 2011
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ALBANY MOLECULAR RESEARCH, INC.
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By:
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/s/ Mark T. Frost
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Name: Mark T. Frost
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Title: Senior Vice President, Administration,
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Chief Financial Officer and Treasurer
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