ORA Postings

• ORA Workplans 
• Setton International Foods 
• Bi-County Farm Bureau Coop Association 
• Genzyme Corporation. Allston, MA. Form 483 (Inspectional Observations). 09/15/08 -10/10/08 (PDF - 379KB) 
• Teva Parenteral Medicines, Inc. Irvine, CA. Form 483 (Inspectional Observations). 7/13/09 - 7/24/09 (PDF - 650KB) 
• Tasty Baking Co Inc. Philadelphia, PA. Form 483 (Inspectional Observations). 07/09/09 – 07/13/09 (PDF - 41KB) 
• Plainview Milk Products Cooperative 
• Quality Formulation Laboratories, Inc. Paterson, NJ. Form 483 (Inspectional Observations) 12/10/08 – 1/13/09 (PDF - 537KB) 
• Trans-Packers Services Corporation. Brooklyn, NY. Form 483 (Inspectional Observations). 06/01/2009 - 07/06/2009 (PDF - 360KB) 
• Nestle USA, Inc. Danville, VA. Form 483 (Inspectional Observations). 06/18/2009 - 07/09/2009 (PDF - 28KB) 
• Stryker Corporation 
• Caraco Pharmaceutical Laboratories 
• Matrixx Initiatives Inc. (Zicam), Scottdale, AZ 483 issued 5/28/2009, EIR signed 5/27/2005, and 483 issued 5/27/2005 (23 pages) (PDF - 2068KB) 
• Peregrina Cheese Company, Brooklyn, NY 483s issued 3/19/03, 2/5/04, 4/5/06, 12/21/07, 2/17/09, 3/17/09 
• Nestle USA, Inc., Danville, VA EIRs for inspections completed 3/12/2009, 11/02/2007, and 2/21/2007 (PDF - 1180KB) 
• Nestle USA, Inc., Danville, VA EIRs for inspection completed 9/12/2006, 9/14/2005, and 7/14/2004 (PDF - 929KB) 
• Clarcon Biological Chemistry Laboratory, Roy, UT. 483 (Inspectional Observations). 04/28/09 – 05/04/09 (PDF - 338KB) 
• General Mills, Minneapolis, Minnesota. Warning Letter response. 05/14/09 (PDF - 450KB) 
• TEVA Animal Health, St. Joseph, MO 483 issued April 21, 2009 (20 pages) (PDF - 1125KB) 
• Del Rey Tortilleria, Inc., Chicago, IL: FDA Form 483 (Inspectional Observations), 12/04/08 – 01/08/09 (3 pages) (PDF - 765KB) 
• Zimmer Durom Cup Recall Packet, 2007-2008 (162 pages) (PDF - 8411KB) 
• Peanut Corporation of America (PCA), Blakely, GA: Consumer Complaints 
• AMAG Pharmaceuticals Inc., Cambridge, MA, FDA Form 483 (Inspectional Observations), 9/18 - 10/14/08 (8 pages) (PDF - 768KB) 
• Medtronic Inc. 
• Sanfilippo John B & Son, Inc., Bainbridge, GA: Establishment Inspection Report (EIR), 6/27 - 7/10/07, (4 pages) (PDF - 217KB) 
• ConAgra Grocery Products, Sylvester, GA: 
• KV Pharmaceutical, Saint Louis, MO, 12/15 — 2/2/09, FDA Form 483 (Inspectional Observations), (37 pages) (PDF - 10564KB) 
• American Blanching Company, Fitzgerald, GA 4/8/08: Establishment Inspection Report (EIR), (5 pages) (PDF - 690KB) 
• Peanut Corporation of America (PCA), Plainview TX, FDA Form 483 (Inspectional Observations) 2/4/09 – 2/26/09; (7 pages) (PDF - 4144KB) 
• Peanut Corporation of America (PCA), Blakely, GA: 
• Marietta Corporation, Cortland, NY, 8/18 – 19/08, Establishment Inspection Report (EIR); (9 pages) (PDF - 427KB) 
• Wyeth Pharmaceutical, Pearl River, NY 8/27-10/8/08, 483 Inspectional Observations, Establishment Inspection Report (EIR):  
• NBTY, Inc. Boca Raton, FL 8/25-9/5/08, 483 Inspectional Observations, Establishment Inspection Report (EIR):  
• Novartis Consumer Health, Lincoln, NE, Establishment Inspection Report (EIR) 9/9 – 9/11/2008, (13 pages) (PDF - 847KB) 
• Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008, (7 pages) (PDF - 709KB) 
• Apotheca, Inc., Woodbine, IA, Inspectional Observations (483), 8/19 – 8/28/2008 , (5 pages) (PDF - 491KB) 
• Advanced Medical Optics, Inc., 483 Inspectional Observations, Santa Ana, CA, dated 05/29/2007 - 06/25/2007, (12 pages) (PDF - 563KB) 
• FDA issued an notice of default letter, dated June 20, 2008 to Dr. Amile A. Korangy, M.D. and the Korangy Radiology Associates 
• FDA issued an adverse determination letter, dated June 3, 2008 to the American National Red Cross. The letter was sent via FAX and Certified Mail. 
• Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008 
• United States v. American National Red Cross, Civil Action No. 93-0949 (JGP), 02/06/2008 (JGP) 
• MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007 
• Shelhigh, Inc., Union, NJ, May 2, 2007, FDA Requested Recall 
• American National Red Cross/Biomedical Services, Washington, D.C., April 4, 2007 Adverse Determination Letter 
• American National Red Cross/Biomedical Services, Washington, D.C., November 15, 2006, Consent Decree Correspondence (regarding September 7, 2006, Adverse Determination Letter, paragraph X), (19 pages, 286 KB)  (PDF - 286KB) 
• American National Red Cross/Biomedical Services, Washington, D.C., November 21, 2006, NYPR Adverse Determination Letter 
• American National Red Cross/Biomedical Services, Washington, D.C., September 7, 2006, Adverse Determination Letter and Related Nov. 15th, 2006 Consent Decree Correspondence 
• American National Red Cross/Biomedical Services, Washington, D.C., July 27, 2006 Adverse Determination Letter 
• Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006 and Warning Letter dated 06/30/2006 
• Bausch & Lomb, Inc., 483 Inspectional Observations, Greenville, SC, dated 03/22/2006 - 05/15/2006, Manufacturer and Repackager/Relabeler establishment types 
• Andrx Pharmaceutical, Inc., 483 Inspectional Observations, Fort Lauderdale, FL, dated 03/06/2006 - 04/18/2006 
• Utah Medical Products, Inc. (UTMD), Salt Lake City, Utah - 483 Inspectional Observations (483) and Establishment Inspection Reports (EIR) for inspections in 2001-2004*.  
• Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006 
• Boston Scientific, 483 Inspectional Observations, six locations:  
• Diamond Pet Food Processors, Gaston, SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006 
• Guidant Corporation, Saint Paul, MN, September 22, 2005, FDA 483 Inspectional Observations, dated 08/22/2005 - 09/01/2005 
• American National Red Cross/Biomedical Services, Washington, D.C., June 10, 2005 Modified Adverse Determination Letter 
• Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005 
• American National Red Cross/Biomedical Services, Washington, D.C., May 16, 2005 Adverse Determination Letter and Attachment 
• American National Red Cross/Biomedical Services, Washngton, D.C., March 28, 2005, Adverse Determination Letter 
• Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK, November 17, 2004: 
• American National Red Cross/Biomedical Services, Washington, D.C., July 13, 2004 Letter 
• American National Red Cross/Biomedical Services, Washington, D.C., April 2, 2004, Adverse Determination Letter 
• American National Red Cross/Biomedical Services, Washington, D.C., March 8, 2004, Consent Decree Correspondence 
• American National Red Cross/Biomedical Services, Washington, D.C., February 11, 2004, Adverse Determination Letter 
• CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003 
• American National Red Cross/Biomedical Services, Washington, D.C., September 2, 2003, Consent Decree Correspondence 
• American National Red Cross/Biomedical Services, Washington, D.C., July 22, 2003, Adverse Determination Letter 
• American National Red Cross/Biomedical Services, Washington, D.C., April 15, 2003, Amended Consent Decree 
• American National Red Cross/Biomedical Services, Arlington, Virginia, April 14, 2003, Consent Decree Letter 
• Cryolife, Connie J. Jones, Kennesaw, GA, 30144, FDA Inspectional Observations, dated 2/14/2003 
• University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations 
• American National Red Cross/Biomedical Services, Arlington, Virginia , 04/22/2002 to 12/20/2002 FDA Inspectional Observations 
• Gary J. Oulette, Executive Director, American Red Cross, Greater Chesapeake & Potomac Blood Service Region, FDA 483, Insp. Observations (Baltimore) 06/21/2002 posted 07/15/2002 
• Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB, FDA 483 Insp. Observations (Baltimore) 09/07/2001 
• Chi Van Dang, M.D., Ph.D./John Hopkins, Bayview Medical Center, Human Subjects Committee, FDA 483, Insp. Observations (Baltimore) 09/07/2001 
• Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.: FDA 483 Inspectional Observations; (Baltimore) 06/28/2001 
• Schering-Plough, Manati, Puerto Rico: 
• Eli Lilly and Company, Indianapolis, IN. Inspection January 29 to February 23, 2001, Warning Letter, FDA 483 and responses from firm:  
• Bioport Corporation, Lansing, MI, FDA 483, dated 10/10-26/2000; (18 pages) (PDF - 3298KB) 
• New York Blood Center, Inc., New York, NY, Establishment Inspection Report (EIR), 10/29/1996 to 12/20/1996; (35 pages) (PDF - 5118KB) 
• Time Cap Labs, Inc., Farmingdale, NY, FDA 483, inspection 03/26 - 05/05/1998; (11 pages) (PDF - 1599KB) 
• Forest/Inwood Laboratories, Inc., Farmingdale, NY, FDA 483 dated 10/23/1998; (6 pages) (PDF - 394KB)