Impax Laboratories Provides an Update on Recent FDA Site Inspection
June 06 2011 - 7:00AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that
late Friday, June 3, it received a warning letter from the U.S.
Food and Drug Administration (FDA) dated May 31, 2011 related to an
on-site inspection of its Hayward, Calif. manufacturing facility
conducted between December 13, 2010 and January 21, 2011.
In the warning letter, the FDA cited deviations from current
Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals.
The deviations cited related to sampling and testing of in process
materials and drug products, production record review and our
process for investigating the failure of certain manufacturing
batches (or portions of batches) to meet specifications. As a
result of the FDA’s initial inspection results, the Company
conducted a voluntary recall in March of 2011 of five lots of
Fenofibrate capsules 200 mg at the wholesale level and took
additional remedial actions as noted below.
The Company notes that the observations cited in the letter
relate to the Hayward manufacturing facility only, and do not
relate to any of the Company’s other facilities. It also notes that
until remedial action is complete and the FDA has confirmed
compliance with cGMP, approval of pending and new applications
listing the Hayward facility as a manufacturing location of
finished dosage forms may be withheld. The warning letter did not
place restrictions on the Company’s ability to manufacture and ship
product. While during the past three months, the production level
at the Hayward facility was reduced to implement several key
changes in the Company’s quality system, the Company is now
producing product at a normal pace and does not currently plan to
reduce its product manufacturing or hold shipments of finished
product.
Following the initial inspection, the Company took a number of
steps to thoroughly review its manufacturing systems and standards,
including the use of leading consulting firms to assist in that
review. This work is ongoing and the Company is committed to
improving its manufacturing practices. The Company will continue to
work to fully address the FDA’s concerns and to resolve these
issues. The Company will respond to the FDA’s warning letter within
the mandated 15 business day response period.
“Impax remains committed to providing the highest quality
products to our customers and working with the FDA to diligently
resolve any issues,” said Larry Hsu, Ph.D., president and CEO,
Impax Laboratories. “We intend to promptly respond to the FDA’s
letter, and have already begun to implement changes and establish
procedures that address the observations cited during the
inspection. We will work diligently to remedy any outstanding
issues in a timely manner.”
Dr. Hsu concluded, “We don’t anticipate that this manufacturing
setback will delay our ongoing research and development activities.
We expect to continue to develop our generic pipeline of 82
products and two brand products.”
Unless and until the Company’s remedial action is completed to
the FDA’s satisfaction, it is possible that the Company may be
subject to additional regulatory action by the FDA as a result of
the issues raised in the warning letter. The warning letter will be
posted on the FDA’s website at www.fda.gov and, once posted, will
be available for viewing.
Conference Call Information
The Company will host a conference call and Webcast today at
9:00 a.m. ET. The number to call from within the United States is
(877) 273-1376 and (702) 800-7095 internationally. The call can
also be accessed via a live Webcast through the Investor Relations
section of the Company’s Web site, www.impaxlabs.com. A replay of
the conference call will be available shortly after the call for a
period of seven days. To access the replay, dial (800) 642-1687 (in
the U.S.) and (706) 645-9291 (international callers). The access
conference code is 73701231.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded
products. Impax markets its generic products through its Global
Pharmaceuticals division and markets its branded products through
its Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax has developed marketing
partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and
operating income, the ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of
business with any significant customer or a reduction in sales of
any significant product, the impact of competition, the ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the
Taiwan facility, the effect of foreign economic, political, legal
and other risks on operations abroad, the uncertainty of patent
litigation, consumer acceptance and demand for new pharmaceutical
products, the difficulty of predicting Food and Drug Administration
filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications,
the ability to successfully conduct clinical trials, reliance on
alliance and collaboration agreements, the availability of raw
materials, the ability to comply with legal and regulatory
requirements, the regulatory environment, the ability to protect
the Company’s intellectual property, exposure to product liability
claims and other risks described in the Company’s periodic reports
filed with the Securities and Exchange Commission. Forward-looking
statements speak only as to the date on which they are made, and
Impax undertakes no obligation to update publicly or revise any
forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
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