Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - INVACARE CORP | april272017release.htm |
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):
April 26, 2017
INVACARE CORPORATION
(Exact name of Registrant as specified in its charter)
Ohio | 001-15103 | 95-2680965 |
(State or other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (I.R.S. Employer Identification Number) |
One Invacare Way, P.O. Box 4028, Elyria, Ohio 44036
(Address of principal executive offices, including zip code)
(440) 329-6000
(Registrant’s telephone number, including area code)
————————————————————————————————
(Former name, former address and former fiscal year, if changed since last report)
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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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01. | Other Events. |
On April 26, 2017, Invacare Corporation (the “company”) submitted its 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.
Based on the terms of the consent decree, the company expects FDA 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.
For more information about the consent decree, refer to the company's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the 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 company’s 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. | |
Exhibit Number | Description of Exhibit |
99.1 | Press Release, dated April 27, 2017 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
INVACARE CORPORATION | ||
(Registrant) | ||
Date: April 27, 2017 | By: | /s/ Robert K. Gudbranson |
Name: | Robert K. Gudbranson | |
Title: | Senior Vice President and Chief Financial Officer | |
Exhibit Index
Exhibit Number | Description of Exhibit |
99.1 | Press Release, dated April 27, 2017 |