INVACARE CORPORATION (NYSE:IVC) Files An 8-K Other Events
Item 8.01.
|
Other Events.
|
written report to the United States Food and Drug Administration
(FDA) in accordance with paragraph 5(H) of the consent decree
related to its Corporate and Taylor Street facilities in Elyria,
Ohio. The “5(H) Report” details the company’s actions to correct
findings from prior FDA and third-party expert inspections and to
ensure that the quality system and controls at the Corporate and
Taylor Street facilities have achieved and will sustain compliance
with applicable FDA requirements. The company filed the 5(H) Report
with FDA following the Agency’s recent acceptance of the third
expert certification report that was submitted to FDA on February
9, 2016.
to initiate inspection of the company’s Corporate and Taylor
Street facilities within 30 days. The company cannot predict the
length of the inspection, nor any remaining work that may be needed
to meet FDA’s requirements for resuming full operations at the
impacted facilities. The company continues to emphasize a culture
of quality and compliance at its facilities, and it looks forward
to demonstrating its progress to FDA during its inspection.
company’s Form 10-K and Form 10-Q filings with the Securities and
Exchange Commission.
meaning of the Safe Harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are those
that describe future outcomes or expectations that are usually
identified by words such as will, should, could, plan, intend,
expect, continue, forecast, believe, and anticipate and include,
for example, any statement made regarding the company’s future
results. Actual results may differ materially as a result of
various risks and uncertainties, including any circumstances or
developments that might delay or adversely impact FDA’s acceptance
of the 5(H) report, or FDA’s inspection of the company’s
Corporate and Taylor Street facilities, and those other risks and
uncertainties expressed in the cautionary statements and risk
factors in the companys annual report on Form 10-K, quarterly
reports on Form 10-Q and other filings with the Securities and
Exchange Commission. The company may not be able to predict and may
have little or no control over many factors or events that may
influence its future results and, except as required by law, shall
have no obligation to update any forward-looking statements.
|
(d) Exhibits.
|
|
|
|
|
|
Exhibit Number
|
Description of Exhibit
|
|
|
|
|
99.1
|
Press Release, dated April 27, 2017
|
About INVACARE CORPORATION (NYSE:IVC)
Invacare Corporation is a manufacturer and distributor for medical equipment used in non-acute care settings. The Company’s geographical segments are Europe; North America, which includes North America/Home Medical Equipment (North America/HME) and Institutional Products Group (IPG) segments, and Asia/Pacific. The Company manufactures and distributes three product categories: mobility and seating, lifestyle and respiratory therapy. It provides medical device solutions for congenital (cerebral palsy, muscular dystrophy and spina bifida), acquired (stroke, spinal cord injury, traumatic brain injury, post-acute recovery and pressure ulcers) and degenerative (amyotrophic lateral sclerosis, multiple sclerosis, chronic obstructive pulmonary disease (COPD), elderly and bariatric) ailments. The Company sells its products to home medical equipment providers with retail and e-commerce channels, residential living operators, distributors and government health services. INVACARE CORPORATION (NYSE:IVC) Recent Trading Information
INVACARE CORPORATION (NYSE:IVC) closed its last trading session up +0.20 at 13.25 with 287,846 shares trading hands.
