Biological Product Deviation Report FORM FDA 3486 PSC Publishing Services

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Specifications	Biological Product Deviation Report FORM FDA 3486 PSC Publishing Services
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION BIOLOGICAL PRODUCT DEVIATION REPORT FDA USE ONLY BPD ID:

Specifications	Biological Product Deviation Report FORM FDA 3486 PSC Publishing Services
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Content	DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION BIOLOGICAL PRODUCT DEVIATION REPORT FDA USE ONLY BPD ID: BPD No. Date Received: A. FACILITY INFORMATION 1. Reporting Establishment Information * Reporting Establishment Name * State B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION Street Address Line 1 Street Address Line 2 City CountryZip Code Telephone # Point of Contact E-mail 2. Reporting Establishment Identification Number FDA Registration # 5.* Description of BPD (use Page 2 for additional space) CLIA # 4.Establishment Identification Number 3.If the BPD occurred somewhere other than the abovefacility, please complete this Section and Section A4;otherwise, continue on to Section B1. * Establishment Name * State PSC Publishing Services (301) 443-6740 2.Date BPD Occurred 3.Date BPD Discovered 4.Date BPD Reported 6.* Description of Contributing Factors or Root Cause (use Page 3 for additional space) C. UNIT / PRODUCT INFORMATION EF Please check the type of product: 7.* Follow-Up (use Page 4 for additional space) Page 1 of 8 Street Address Line 1 Street Address Line 2 City CountryZip Code FDA Registration # CLIA # Form Approved: OMB No. 0910-0458 Expires: 1/31/2014 Blood Non-Blood 8.* Please Enter the 6 Character BPD Code (Continued on Page 5) FORM FDA 3486 (1/11) (Continued on Page 6) See OMB Statement on Page 8. * Indicates required information Date Reviewed: 1.Establishment Tracking #
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Following Datasheets	UCM070945-1_1 (12 pages) UCM070981 (33 pages) UCM071234_1 (2 pages) UCM071253_1 (3 pages) UCM071296_1 (3 pages) UCM071297_1 (3 pages) UCM071436_1 (1298 pages) UCM071550_1 (15 pages) UCM071554_1 (7 pages) UCM071562_1 (18 pages)
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