ORA Postings

Title	Posted Date
U.F. Union International Food Co., Inc., Union City, CA, EIR signed 7/24/2009	01/25/10
Quesos Mi Pueblito, LLC, Passaic, NJ FDA Form 483 signed 9/3/09	01/20/10
McNeil Healthcare, LLC, Las Piedras, PR 483 issued 1/8/2010 (Tylenol)	01/13/10
Matrixx Initiatives Inc.	01/13/10
Won Feng Trading Inc, Nashville, TN FDA Form 483 issued 11/12/2009	01/07/10
Willamette Shelling, Inc.	12/30/09
Unilever Covington, Covington, TN FDA Form 483 12/11/2009 (1 page)	12/28/09
Pepsi Bottling Group, LLC	12/24/09
Genzyme Corporation, Allston, MA, FDA Form 483 11/13/2009	11/25/09
American Red Cross 2009 Adverse Determination Letters	11/12/09
Haifa Smoked Fish, Inc.	11/10/09
Aunt Mid's Produce Company	10/15/09
Care-Tech Labs Inc., Lenexa, KS 483 issued 5/22/2008	09/23/09
Care-Tech Labs Inc., Signed Consent Decree issued 9/8/2009	10/15/09
American National Red Cross / Biomedical Services	09/23/09
ORA Workplans	10/19/09
Setton International Foods	11/12/09
Bi-County Farm Bureau Coop Association	08/11/09
Genzyme Corporation. Allston, MA. Form 483 (Inspectional Observations). 09/15/08 -10/10/08	08/04/09
Teva Parenteral Medicines, Inc. Irvine, CA. Form 483 (Inspectional Observations). 7/13/09 - 7/24/09	07/31/09
Tasty Baking Co Inc. Philadelphia, PA. Form 483 (Inspectional Observations). 07/09/09 – 07/13/09	07/24/09
Plainview Milk Products Cooperative	07/21/09
Quality Formulation Laboratories, Inc. Paterson, NJ. Form 483 (Inspectional Observations) 12/10/08 – 1/13/09	07/20/09
Trans-Packers Services Corporation. Brooklyn, NY. Form 483 (Inspectional Observations). 06/01/2009 - 07/06/2009	07/15/09
Nestle USA, Inc. Danville, VA. Form 483 (Inspectional Observations). 06/18/2009 - 07/09/2009	07/10/09
Stryker Corporation	07/15/09
Caraco Pharmaceutical Laboratories	10/01/09
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	07/02/09
Nestle USA, Inc., Danville, VA EIRs for inspections completed 3/12/2009, 11/02/2007, and 2/21/2007	06/30/09
Nestle USA, Inc., Danville, VA EIRs for inspection completed 9/12/2006, 9/14/2005, and 7/14/2004	06/25/09
Clarcon Biological Chemistry Laboratory, Roy, UT. 483 (Inspectional Observations). 04/28/09 – 05/04/09	06/17/09
General Mills, Minneapolis, Minnesota. Warning Letter response. 05/14/09	06/17/09
TEVA Animal Health, St. Joseph, MO 483 issued April 21, 2009 (20 pages)	05/28/09
Del Rey Tortilleria, Inc., Chicago, IL: FDA Form 483 (Inspectional Observations), 12/04/08 – 01/08/09 (3 pages)	05/29/09
Zimmer Durom Cup Recall Packet, 2007-2008 (162 pages)	05/27/09
Peanut Corporation of America (PCA), Blakely, GA: Consumer Complaints	06/25/09
AMAG Pharmaceuticals Inc., Cambridge, MA, FDA Form 483 (Inspectional Observations), 9/18 - 10/14/08 (8 pages)	05/27/09
Medtronic Inc.	12/09/09
Sanfilippo John B & Son, Inc., Bainbridge, GA: Establishment Inspection Report (EIR), 6/27 - 7/10/07, (4 pages)	06/04/09
ConAgra Grocery Products, Sylvester, GA:	05/27/09
KV Pharmaceutical, Saint Louis, MO, 12/15 — 2/2/09, FDA Form 483 (Inspectional Observations), (37 pages)	06/04/09
American Blanching Company, Fitzgerald, GA 4/8/08: Establishment Inspection Report (EIR), (5 pages)	06/04/09
Peanut Corporation of America (PCA), Plainview TX, FDA Form 483 (Inspectional Observations) 2/4/09 – 2/26/09; (7 pages)	06/01/09
Peanut Corporation of America (PCA), Blakely, GA:	04/21/09
Marietta Corporation, Cortland, NY, 8/18 – 19/08, Establishment Inspection Report (EIR); (9 pages)	06/02/09
Wyeth Pharmaceutical, Pearl River, NY 8/27-10/8/08, 483 Inspectional Observations, Establishment Inspection Report (EIR):	01/27/09
NBTY, Inc. Boca Raton, FL 8/25-9/5/08, 483 Inspectional Observations, Establishment Inspection Report (EIR):	01/16/09
Novartis Consumer Health, Lincoln, NE, Establishment Inspection Report (EIR) 9/9 – 9/11/2008, (13 pages)	06/02/09
Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008, (7 pages)	06/02/09
Apotheca, Inc., Woodbine, IA, Inspectional Observations (483), 8/19 – 8/28/2008 , (5 pages)	06/02/09
Advanced Medical Optics, Inc., 483 Inspectional Observations, Santa Ana, CA, dated 05/29/2007 - 06/25/2007, (12 pages)	06/02/09
FDA issued an notice of default letter, dated June 20, 2008 to Dr. Amile A. Korangy, M.D. and the Korangy Radiology Associates	06/26/09
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.	06/26/09
Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008	06/26/09
United States v. American National Red Cross, Civil Action No. 93-0949 (JGP), 02/06/2008 (JGP)	06/26/09
MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007	06/26/09
Shelhigh, Inc., Union, NJ, May 2, 2007, FDA Requested Recall	06/26/09
Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006 and Warning Letter dated 06/30/2006	06/29/09
Bausch & Lomb, Inc., 483 Inspectional Observations, Greenville, SC, dated 03/22/2006 - 05/15/2006, Manufacturer and Repackager/Relabeler establishment types	06/29/09
Andrx Pharmaceutical, Inc., 483 Inspectional Observations, Fort Lauderdale, FL, dated 03/06/2006 - 04/18/2006	06/29/09
Utah Medical Products, Inc. (UTMD), Salt Lake City, Utah - 483 Inspectional Observations (483) and Establishment Inspection Reports (EIR) for inspections in 2001-2004*.	01/12/09
Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006	06/29/09
Boston Scientific, 483 Inspectional Observations, six locations:	01/13/09
Diamond Pet Food Processors, Gaston, SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006	06/30/09
Guidant Corporation, Saint Paul, MN, September 22, 2005, FDA 483 Inspectional Observations, dated 08/22/2005 - 09/01/2005	06/30/09
Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005	06/30/09
Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK, November 17, 2004:	01/14/09
CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003	07/06/09
Cryolife, Connie J. Jones, Kennesaw, GA, 30144, FDA Inspectional Observations, dated 2/14/2003	07/10/09
University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations	07/10/09
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	07/13/09
Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB, FDA 483 Insp. Observations (Baltimore) 09/07/2001	07/13/09
Chi Van Dang, M.D., Ph.D./John Hopkins, Bayview Medical Center, Human Subjects Committee, FDA 483, Insp. Observations (Baltimore) 09/07/2001	07/13/09
Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.: FDA 483 Inspectional Observations; (Baltimore) 06/28/2001	07/13/09
Schering-Plough, Manati, Puerto Rico:	01/21/09
Eli Lilly and Company, Indianapolis, IN. Inspection January 29 to February 23, 2001, Warning Letter, FDA 483 and responses from firm:	01/21/09
Bioport Corporation, Lansing, MI, FDA 483, dated 10/10-26/2000; (18 pages)	07/13/09
New York Blood Center, Inc., New York, NY, Establishment Inspection Report (EIR), 10/29/1996 to 12/20/1996; (35 pages)	07/13/09
Time Cap Labs, Inc., Farmingdale, NY, FDA 483, inspection 03/26 - 05/05/1998; (11 pages)	07/13/09
Forest/Inwood Laboratories, Inc., Farmingdale, NY, FDA 483 dated 10/23/1998; (6 pages)	07/13/09