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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 SEPTEMBER 28, 1999 Date of Report (Date of earliest event reported) ABBOTT LABORATORIES (Exact name of registrant as specified in its charter) -------------------------------------------------------- ILLINOIS 1-2189 36-0698440 (State or other (Commission File Number) (I.R.S. Employer Jurisdiction of Identification No.) Incorporation) ------------------------------------------------------- 100 ABBOTT PARK ROAD ABBOTT PARK, ILLINOIS 60064-6400 (Address of principal executive offices)(Zip Code) Registrant's telephone number, including area code: (847) 937-6100 ------------------------------------------------------- ITEM 5. OTHER EVENTS. On September 28, 1999, Abbott announced that it has been notified by the government of alleged noncompliance with the Food and Drug Administration's Quality System Regulation at Abbott's Diagnostics Division facilities in Lake County, Illinois. Although Abbott believes that it is in substantial compliance with these regulations, FDA disagrees. The parties are in discussions over a proposed consent decree. If those discussions are not successful, the government has advised the company that it will file a complaint for injunctive relief which would include the cessation of manufacturing and sale for a period of time of a number of diagnostic products. The company would resist that suit. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (c) Exhibits. Exhibit No. Description ----------- ----------- Exhibit 99.1 Press Release dated September 28, 1999. SIGNATURE Pursuant to the requirements 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. ABBOTT LABORATORIES /s/ Gary P. Coughlan ---------------------- By: Gary P. Coughlan Senior Vice President, Finance and Chief Financial Officer Date: September 29, 1999
ABBOTT LABORATORIES IN DISCUSSION WITH THE FOOD AND DRUG ADMINISTRATION REGARDING COMPLIANCE ISSUES IN DIAGNOSTICS DIVISION Abbott Park, Ill., September 28, 1999 -- Abbott Laboratories announced today that it has been notified by the government of alleged noncompliance with the Food and Drug Administration's Quality System Regulation at Abbott's Diagnostics Division facilities in Lake County, Illinois. Although Abbott believes that it is in substantial compliance with these regulations, FDA disagrees. The parties are in discussions over a proposed consent decree. If those discussions are not successful, the government has advised the company that it will file a complaint for injunctive relief which would include the cessation of manufacturing and sale for a period of time of a number of diagnostic products. The company would resist that suit. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 56,000 people and markets its products in more than 130 countries. In 1998, the company's sales and net earnings were $12.5 billion and $2.3 billion, respectively, with diluted earnings per share of $1.51. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com. ###