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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):
May 3, 2001
PERRIGO COMPANY
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(Exact name of registrant as specified in charter)
MICHIGAN 0-19725 38-2799573
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(State of other (Commission (I.R.S. Employer
Jurisdiction of File Number) Identification
Incorporation) Number)
515 Eastern Avenue, Allegan, Michigan 49010
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:
(616) 673-8451
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ITEM 5. Other Events
Government Regulations - Food and Drug Administration
On May 2, 2001, the Company was notified by the FDA Detroit
District Office that it has recommended that Abbreviated New Drug
Applications (ANDAs) for two of the Company's products be approved for
manufacturing at its Allegan, Michigan facility. This recommendation
grew out of an FDA inspection and follow-up review that was conducted
in March 2001, following the FDA's issuance of a Warning Letter in
August 2000. It is now anticipated that final approval of the Company's
ANDAs will not be withheld due to issues identified in the August 2000
Warning Letter.
In August 2000, the Company received a Warning Letter from the
FDA primarily related to manufacturing issues identified during the
FDA's April 2000 inspection of its Allegan facilities. The Warning
Letter also identified certain issues related to the Company's Quality
Systems. In response to the Warning Letter, the Company met with the
FDA to discuss the manufacturing and Quality Systems issues. The
Company is implementing remedial action to address the manufacturing
issues and has completed a Global Improvement Plan (GIP) with the help
of outside consultants to ensure that the Company's Quality Systems
comply with "Current Good Manufacturing Practices" (cGMP) on an
on-going basis. The GIP Plan includes a review of the Quality Systems,
formulation of revisions to the Quality Systems, a plan to implement
identified changes and a plan to audit and measure the effectiveness of
the corrective action taken. The Company has already taken
comprehensive corrective action as outlined in the GIP Plan and will
continue to implement the GIP Plan on an on-going basis to ensure
compliance with cGMP.
The manufacturing, testing, packaging, distribution, labeling,
advertising and sale of the Company's products are subject to
regulation by one or more United States agencies, including the FDA.
The FDA exercises authority over three aspects of the Company's
business: (i) the operation of manufacturing, testing and packaging
facilities, (ii) the labeling and marketing of over-the-counter (OTC)
pharmaceutical drug products, and (iii) the labeling and marketing of
dietary supplements.
On an on-going basis, the FDA reviews the safety and efficacy
of OTC pharmaceutical products and monitors the labeling, advertising
and other matters related to the promotion and sale of such products.
The FDA also regulates the facilities and procedures used to
manufacture OTC pharmaceuticals and all facilities must be registered
with the FDA and all products made in those facilities must be
manufactured in accordance with cGMP established by the FDA. Compliance
with cGMP guidelines entails a dedication of substantial resources and
requires significant costs.
The FDA performs periodic inspections to ensure that the
Company's facilities remain in compliance with cGMP regulations. The
failure of a facility to be in compliance may lead to regulatory action
that could result in production interruptions, product recalls or
delays in new drug approvals. The impact of one or more of these
actions could have a material adverse effect on the Company's business.
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SIGNATURES
Pursuant to the requirement 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.
PERRIGO COMPANY
(Registrant)
By: /s/ Douglas R. Schrank
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Dated: May 3, 2001 Douglas R. Schrank
Executive Vice President and
Chief Financial Officer