UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
LEINER HEALTH PRODUCTS INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of
incorporation or organization)
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333-33121
(Commission File Number)
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95-3431709
(IRS Employer Identification
Number) |
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901 East 233rd Street, Carson, California
(Address of principal executive offices)
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90745
(Zip Code) |
Registrant’s telephone number, including area code:
(310) 835-8400
N/A
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 8.01 Other Events.
On
August 29, 2007, Leiner Health Products LLC, our principal operating subsidiary (the
“Company”), received a Warning Letter from the United States Food and Drug Administration (
“FDA”)
in connection with the FDA’s January 22 through March 16 inspection of
the Company’s
over-the-counter (
“OTC”) drug operations in Fort Mill, South Carolina.
As previously announced,
the Company had received a list of Inspection Observations on Form
483 (the
“Form 483”) on
March 16, 2007 containing inspection observations concerning
product quality and deficiencies in
the Company’s compliance with current good
manufacturing practices (
“cGMP”) for OTC drug operations at its Fort Mill OTC facility.
The Warning Letter acknowledges
the Company’s corrective action plans, reiterates the
seriousness of the issues outlined in the Form 483, and indicates that the FDA expects continued and comprehensive effort by
the Company to resolve cGMP issues in all locations.
The Company will submit a formal response to the Warning Letter outlining the significant
actions already undertaken, including the strengthening and restructuring its OTC Quality Unit. In
addition to reaffirming its prior commitments,
the Company will clarify its go-forward priorities and plans for all locations.
The Company continues to cooperate fully with the FDA and will seek FDA concurrence before
restarting its OTC operations.
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