510-B - FORM FDA 483 (2 pgs)

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER Minneapolis District 240 Hennipin Ave. Minneapolis, MN 55401 (612) 787-3904 DATE(S) OF INSPECTION 1/5-7/2004 FEI NUMBER 0000112233 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO: William S. Gundstrom, Vice President, Production FIRM NAME Topline Pharmaceuticals "T.L.P. " STREET ADDRESS 2136 Elbe Place CITY, STATE AND ZIP CODE Jackston, MN 55326 TYPE OF ESTABLISHMENT INSPECTED Tablet Repacker THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS, AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT, CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE OBJECTION OR ACTION WITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESS ABOVE. DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED: List your observations in a logical and concise manner. (See IOM 512, 512.01, & 512.02) SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGNATURE Sidney H. Rogers EMPLOYEE(S) NAME AND TITLE (Print or Type) Sidney H. Rogers, Investigator DATE ISSUED 1/7/2004 FORM FDA 483 ( 4/03) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Reverse Text on Page: The observations of objectional conditions and practices listed on the front of this form are reported: Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration. Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC374(b)) provides: "Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."