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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):
March 6, 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 or 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
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 Food and Drug Administration (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 "Current Good Manufacturing
Practices" (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.
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, Michigan manufacturing 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 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.
Based on discussions with the FDA, a reinspection of the Allegan facilities
to review the actions taken to correct the manufacturing issues cited in
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the Warning Letter was expected. The FDA initiated their inspection and
follow-up review on March 5, 2001. The Company cannot predict that its remedial
actions will resolve the FDA's concerns or whether the FDA will take any further
action.
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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: March 6, 2001 Douglas R. Schrank
Executive Vice President and
Chief Financial Officer