Wellbutrin XL NDA 21-515

3-AUG-2003 FDA CDER EES Page 2 of 3

ESTABLISHMENT EVALUATION REQUEST

DETAIL REPORT

Milestone Name Date Type Insp. Date Decision & Reason Creator

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SUBMITTED TO OC 27-SEP-2002 MCLAMORES

OC RECOMMENDATION 30-SEP-2002 ACCEPTABLE DAMBROGIOJ

BASED ON PROFILE

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Establishment: CFN 1033964 FEI 1033964

GLAXO INC

1011 NORTH ARENDELL AVE

ZEBULON, NC 27597

MF No: AADA:

Responsibilities: FINISHED DOSAGE PACKAGER

Profile: TCT OAI Status: NONE

Milestone Name Date Type Insp. Date Decision& Reason Creator

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SUBMITTED TO OC 27-SEP-2002 MCLAMORES

SUBMITTED TO DO 27-SEP-2002 GMP FERGUSONS

ASSIGNED INSPECTION T 12-NOV-2002 PS LANDREWS

INSPECTION SCHEDULED 14-NOV-2002 26-APR-2003 LANDREW1@OR

INSPECTION PERFORMED 17-APR-2003 17-APR-2003 LANDREWS

INSPECTION PERFORMED 17-APR-2003 17-APR-2003 LANDREW1@OR

AUTOMATIC WITHHOLD STATUS ISSUED BY FACTS, DUE TO FIRM BEING OUT OF BUSINESS OR MERGED

DO RECOMMENDATION 21-APR-2003 ACCEPTABLE LANDREWS

INSPECTION

INSPECTION CONDUCTED ON 4/15-17/03. NO 483 ISSUED. PROFILE CLASS IS ACCEPTABLE.

[?] RECOMMENDATION 21-APR-2003 ACCEPTABLE FERGUSONS

DISTRICT RECOMMENDATION

DO RECOMMENDATION 31-JUL-2003 ACCEPTABLE LANDREWS

DISTRICT RECOMMENDATION

OC RECOMMENDATION 31-JUL-2003 ACCEPTABLE FERGUSONS