PV_abbott_warning_letter - D EPARTMENTOFHEALTH &...

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DEPARTMENTOFHEALTH & HUMANSERVICES Food and Drug Administration Chicago District July 19,2002 300 S. Riverside Plaza, Suite 550 South Chicago, Illinois 60606 Telephone: 312-353-5663 WARNINGLE ’ ITE~ Cm-21-02 CERTIFIEDMNL R~ ‘URNRI@~PTREOUESTED Mr. Miles C. White Chief Executive Oflicer Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 Dear Mr. White: From January 7 through January 28,2002, and March 21 through April 3,2002, investigators from the Food and Drug Administration ’s (FDA) Chicago District office conducted inspections of your tirm located at the above address. The purpose of these inspections was to determine your firm ’s compliance with the postmarketing adverse drug experience reporting requirements of Section SOS(k) of the Federal Food, Drug, and Cosmetic Act ( “the Act ”) and Title 2 1, Code of Federal Rermlatiw (CFR), Part 3 14.80. We note that several of the identified deficiencies arise from the product safety operations of Knoll Pharmaceuticals before Abbott Laboratories acquired the worldwide pharmaceutical business of BASF AG, which included the purchase of Knoll Pharmaceuticals, in March 200 1. Knoll Pharmaceuticals is now a subsidiary of your firm, and you have completed integration of the Knoll product safety operations into Abbott ’s operations. As such, your firm has assumed the responsibility for reporting adverse drug experiences for that subsidiary. Based on our review of the inspection reports and reports submitted by your firm to FDA, we conclude that your hn failed to comply with Section SOS(k)(l) of the Act and 21 CFR 3 14.80. Section 505(k)(l) requires an applicant to establish and maintain records, and report data relating to clinical experience and other data or information for drugs for which au approval of an application tied under 505(b) or 505(i) is in effect. Deviations from the 21 CFR 314.80 include the following: (1) ln violation of 21 CFR 31480(c)(l)(i), your firm did not submit serious and unexpected adverse drug experience reports in several cases to FDA within 15 calendar days of initial receipt of the information. For example, our investigator observed that for the period &om January 1, 2000 to October 3 1,2001, there were eighteen 15-day alert reports submitted late to FDA. These
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Abbott Labomtoties Page 2 Product Jv& Control No. &¶t%.Receifl Datesent m I2& $0 FDA Norvir Biaxin ProSom ProSom ProSom Norvir Biaxin Meridia Meridia 2/27/o 1 3/2/01 %29/01 4/2WOl 3/29/o 1 UlWOO 7/l o/o0 8niOl 10/16/01 10/8/01 lO/YOl 10/10/01 4/l 9100 7/23/o 1 + * 161 228 132 162 195 63 377 *Your firm incorrectly categorixed these reports as periodic adverse drug experience reports, which are required to be subrnittcd to FDA at quarterly intervals for three years aAer the date of approval of an application. Because
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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PV_abbott_warning_letter - D EPARTMENTOFHEALTH &...

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