| Alexion Pharmaceuticals, Inc. |
May 03, 2013 |
| Novartis Consumer Health |
April 29, 2013 |
| 2013 Pharmacy Inspections |
April 29, 2013 |
| Hospira Inc. |
April 17, 2013 |
| St. Jude Medical |
April 05, 2013 |
| Impax Laboratories, Inc. |
March 29, 2013 |
| ORA Workplans |
March 15, 2013 |
| Andrx Pharmaceutical, Inc., Fort Lauderdale, FL, 483 dated 03/06/2006 - 04/18/2006 |
March 12, 2013 |
| American National Red Cross Biomedical Services, Adverse Determination Letter, Dated 6/3/2008 |
March 12, 2013 |
| Kasel Associates Industries, Inc., Denver, CO, 483 Issued 9/28/2012 |
February 13, 2013 |
| Hill-Rom, Inc., Batesville, IN, 483 Issued 1/11/2013 |
February 08, 2013 |
| RTI Biologics, Inc. |
December 26, 2012 |
| Celltex Therapeutics Corporation, Sugarland, TX, 483 Issued 4/27/2012 |
December 06, 2012 |
| Alaunus Pharmaceutical LLC, Framingham, MA, 483 Issued 11/16/2012 |
November 19, 2012 |
| Ameridose |
October 31, 2012 |
| New England Compounding Center (NECC) |
October 25, 2012 |
| Shelhigh, Inc., Union, NJ, May 2, 2007, FDA Requested Recall |
October 22, 2012 |
| MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007 |
October 22, 2012 |
| United States v. American National Red Cross, Civil Action No. 93-0949 (JGP), 02/06/2008 (JGP) |
October 22, 2012 |
| Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008 |
October 22, 2012 |
| Johnson and Johnson |
October 19, 2012 |
| Sunland, Inc. |
October 11, 2012 |
| McNeil Healthcare |
October 05, 2012 |
| Chamberlain Farms Inc., Owensville, IN, 483 Issued 8/31/12 |
October 01, 2012 |
| Cryolife, Connie J. Jones, Kennesaw, GA, 30144, FDA Inspectional Observations, dated 2/14/2003 |
September 13, 2012 |
| Pet Jerky Consumer Complaints Received by ORA District Consumer Complaint Coordinators (January 1, 2007 - July 2, 2012) |
September 06, 2012 |
| San Francisco Herb and Natural Food Company, Fremont, CA 483 Issued 7/16/2012 |
August 20, 2012 |
| Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.: FDA 483 Inspectional Observations; (Baltimore) 06/28/2001 |
July 17, 2012 |
| Jerky Pet Food Lab Samples Analyzed - 1/1/2007 - 7/2/2012 |
July 17, 2012 |
| Egg Rule Assignment 483s |
July 12, 2012 |
| Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006 |
July 11, 2012 |
| Diamond Pet Food Processors, Gaston, SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006 |
July 11, 2012 |
| Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005 |
July 11, 2012 |
| CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003 |
July 11, 2012 |
| Exemplar Pharmaceuticals LLC, Fall River, MA 483 issued 3/21/2012 |
July 10, 2012 |
| Egg Rule Assignment Establishment Inspection Reports |
June 27, 2012 |
| Infupharma, LLC |
May 15, 2012 |
| Diamond Pet Food Processors of SC LLC, Gaston, SC, 483 Issued 4/20/2012 |
May 15, 2012 |
| Genentech Inc., South San Francisco, CA 483 issued 9/27/2011 |
May 09, 2012 |
| American National Red Cross / Biomedical Services |
April 25, 2012 |
| Snokist Growers |
April 13, 2012 |
| IntelliCell Biosciences, Inc., New York, NY 483 issued 12/12/2011 |
April 04, 2012 |
| APP Pharmaceuticals, Grand Island, NY 483 issued 7/8/2011 |
March 15, 2012 |
| Regeneron Pharmaceuticals, Inc., Rensselaer, NY 483 issued 3/31/2010 |
March 02, 2012 |
| Jensen Farms |
February 09, 2012 |
| H & P Industries, Inc. (Triad Group) |
January 25, 2012 |
| Integra LifeSciences |
January 13, 2012 |
| CooperVision, Inc. |
December 22, 2011 |
| Akorn, Inc. |
December 21, 2011 |
| Jazz Pharmaceuticals, Inc., Palo Alto, CA 483 issued 5/6/2011 |
December 16, 2011 |
| Sandoz, Inc. (Novartis) |
December 12, 2011 |
| Ben Venue Laboratories |
December 06, 2011 |
| Zimmer Inc., Warsaw, IN 483 issued 7/22/2011 |
November 21, 2011 |
| Invacare Corporation |
November 18, 2011 |
| Thermo Pac LLC (Simply Thick) |
November 11, 2011 |
| Delta Airlines Inc., Atlanta, GA 483 issued 2/2/2011 |
October 28, 2011 |
| Professional Disposables International and Nice Pak Products |
September 29, 2011 |
| Sprouters Northwest Inc., Kent, WA 483 issued 1/21/2011 |
September 20, 2011 |
| Cetero Research |
July 22, 2011 |
| Depuy Orthopaedics |
April 14, 2011 |
| Terumo Cardiovascular Systems Corporation |
April 12, 2011 |
| Bravo Farms Cheese, LLC |
April 04, 2011 |
| Tiny Greens. Urbana, IL 483 issued 1/28/2011 |
February 04, 2011 |
| Duran and Sons LLC Derry, NM 87933 483 issued 11/22/2010 |
December 23, 2010 |
| Sally Jackson Cheeses Oroville, WA 98844 483 issued 12/17/2010 |
December 22, 2010 |
| Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK, November 17, 2004: |
December 21, 2010 |
| Utah Medical Products, Inc. (UTMD), Salt Lake City, Utah - 483 Inspectional Observations (483) and Establishment Inspection Reports (EIR) for inspections in 2001-2004*. |
December 21, 2010 |
| NBTY, Inc. Boca Raton, FL 8/25-9/5/08, 483 Inspectional Observations, Establishment Inspection Report (EIR): |
December 21, 2010 |
| Wyeth Pharmaceutical, Pearl River, NY 8/27-10/8/08, 483 Inspectional Observations, Establishment Inspection Report (EIR): |
December 21, 2010 |
| Peanut Corporation of America (PCA), Blakely, GA: |
December 21, 2010 |
| 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 |
December 21, 2010 |
| Caraco Pharmaceutical Laboratories |
December 21, 2010 |
| Stryker Corporation |
December 21, 2010 |
| Plainview Milk Products Cooperative |
December 21, 2010 |
| Bravo Farms Cheese, LLC, Traver, CA 483 issued 12/1/2010 |
December 08, 2010 |
| Gilead Sciences Inc., San Dimas, CA 483 issued 2/12/2010 |
November 24, 2010 |
| Sanger Fresh Cut Produce Co. LLC, San Antonio, TX 483 issued 10/26/2010 |
November 03, 2010 |
| Scenic View Dairy LLC |
November 02, 2010 |
| Estrella Family Creamery, LLC, Montesano, WA 483 issued 9/10/2010 |
October 26, 2010 |
| Abbott Labs, Inc. (Similac) |
October 26, 2010 |
| Scientific Protein Laboratories, LLC |
October 19, 2010 |
| Hillandale Farms of Iowa, Inc., New Hampton, IA 483 issued 8/26/2010 |
August 30, 2010 |
| Quality Egg LLC, Galt, IA 483 issued 8/30/2010 |
August 30, 2010 |
| Unico Holdings Documents |
July 07, 2010 |
| L. Perrigo Co. |
July 07, 2010 |
| Setton International Foods |
May 14, 2010 |
| Genzyme Corporation. Allston, MA. Form 483 (Inspectional Observations). 09/15/08 -10/10/08 |
March 29, 2010 |
| Care-Tech Labs, Inc., St. Louis, MS 483 issued 5/22/2008 |
March 16, 2010 |
| Amylin Pharmaceuticals Inc., West Chester, OH 483 issued 12/23/2009 |
March 11, 2010 |
| Ohm Laboratories, Inc., Gloversville, NY 483 issued 8/12/2009 |
March 11, 2010 |
| Thumb Oilseed Producers' Cooperative, Ubly, MI 483 issued 2/23/2010 |
March 09, 2010 |
| Basic Food Flavors, Inc., North Las Vegas, NV 483 issued 3/4/2010 |
March 09, 2010 |
| Matrixx Initiatives Inc. |
March 01, 2010 |
| Baxter Healthcare Corporation, Cleveland, MS, Form 483 signed 2/5/2010 |
February 17, 2010 |
| Mid-States Closeouts, Inc., Ellsworth, WI 483 signed 12/21/2009 |
February 17, 2010 |
| U.F. Union International Food Co., Inc., Union City, CA, EIR signed 7/24/2009 |
January 25, 2010 |
| Quesos Mi Pueblito, LLC, Passaic, NJ FDA Form 483 signed 9/3/09 |
January 20, 2010 |
| Won Feng Trading Inc, Nashville, TN FDA Form 483 issued 11/12/2009 |
January 07, 2010 |
| Willamette Shelling, Inc. |
December 30, 2009 |
| Unilever Covington, Covington, TN FDA Form 483 12/11/2009 (1 page) |
December 28, 2009 |
| Pepsi Bottling Group, LLC |
December 24, 2009 |
| Genzyme Corporation, Allston, MA, FDA Form 483 11/13/2009 |
November 25, 2009 |
| American Red Cross 2009 Adverse Determination Letters |
November 12, 2009 |
| Haifa Smoked Fish, Inc. |
November 10, 2009 |
| Care-Tech Labs Inc., Signed Consent Decree issued 9/8/2009 |
October 15, 2009 |
| Aunt Mid's Produce Company |
October 15, 2009 |
| Bi-County Farm Bureau Coop Association |
August 11, 2009 |
| Teva Parenteral Medicines, Inc. Irvine, CA. Form 483 (Inspectional Observations). 7/13/09 - 7/24/09 |
July 31, 2009 |
| Tasty Baking Co Inc. Philadelphia, PA. Form 483 (Inspectional Observations). 07/09/09 – 07/13/09 |
July 24, 2009 |
| Quality Formulation Laboratories, Inc. Paterson, NJ. Form 483 (Inspectional Observations) 12/10/08 – 1/13/09 |
July 20, 2009 |
| Trans-Packers Services Corporation. Brooklyn, NY. Form 483 (Inspectional Observations). 06/01/2009 - 07/06/2009 |
July 15, 2009 |
| Forest/Inwood Laboratories, Inc., Farmingdale, NY, FDA 483 dated 10/23/1998; (6 pages) |
July 13, 2009 |
| Time Cap Labs, Inc., Farmingdale, NY, FDA 483, inspection 03/26 - 05/05/1998; (11 pages) |
July 13, 2009 |
| New York Blood Center, Inc., New York, NY, Establishment Inspection Report (EIR), 10/29/1996 to 12/20/1996; (35 pages) |
July 13, 2009 |
| Bioport Corporation, Lansing, MI, FDA 483, dated 10/10-26/2000; (18 pages) |
July 13, 2009 |
| Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB, FDA 483 Insp. Observations (Baltimore) 09/07/2001 |
July 13, 2009 |
| Chi Van Dang, M.D., Ph.D./John Hopkins, Bayview Medical Center, Human Subjects Committee, FDA 483, Insp. Observations (Baltimore) 09/07/2001 |
July 13, 2009 |
| 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 |
July 13, 2009 |
| Nestle USA, Inc. Danville, VA. Form 483 (Inspectional Observations). 06/18/2009 - 07/09/2009 |
July 10, 2009 |
| University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations |
July 10, 2009 |
| Nestle USA, Inc., Danville, VA EIRs for inspections completed 3/12/2009, 11/02/2007, and 2/21/2007 |
June 30, 2009 |
| Guidant Corporation, Saint Paul, MN, September 22, 2005, FDA 483 Inspectional Observations, dated 08/22/2005 - 09/01/2005 |
June 30, 2009 |
| Bausch & Lomb, Inc., 483 Inspectional Observations, Greenville, SC, dated 03/22/2006 - 05/15/2006, Manufacturer and Repackager/Relabeler establishment types |
June 29, 2009 |
| Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006 and Warning Letter dated 06/30/2006 |
June 29, 2009 |
| FDA issued an notice of default letter, dated June 20, 2008 to Dr. Amile A. Korangy, M.D. and the Korangy Radiology Associates |
June 26, 2009 |
| Peanut Corporation of America (PCA), Blakely, GA: Consumer Complaints |
June 25, 2009 |
| Nestle USA, Inc., Danville, VA EIRs for inspection completed 9/12/2006, 9/14/2005, and 7/14/2004 |
June 25, 2009 |
| General Mills, Minneapolis, Minnesota. Warning Letter response. 05/14/09 |
June 17, 2009 |
| Clarcon Biological Chemistry Laboratory, Roy, UT. 483 (Inspectional Observations). 04/28/09 – 05/04/09 |
June 17, 2009 |
| American Blanching Company, Fitzgerald, GA 4/8/08: Establishment Inspection Report (EIR), (5 pages) |
June 04, 2009 |
| KV Pharmaceutical, Saint Louis, MO, 12/15 — 2/2/09, FDA Form 483 (Inspectional Observations), (37 pages) |
June 04, 2009 |
| Advanced Medical Optics, Inc., 483 Inspectional Observations, Santa Ana, CA, dated 05/29/2007 - 06/25/2007, (12 pages) |
June 02, 2009 |
| Apotheca, Inc., Woodbine, IA, Inspectional Observations (483), 8/19 – 8/28/2008 , (5 pages) |
June 02, 2009 |
| Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008, (7 pages) |
June 02, 2009 |
| Novartis Consumer Health, Lincoln, NE, Establishment Inspection Report (EIR) 9/9 – 9/11/2008, (13 pages) |
June 02, 2009 |
| Marietta Corporation, Cortland, NY, 8/18 – 19/08, Establishment Inspection Report (EIR); (9 pages) |
June 02, 2009 |
| Peanut Corporation of America (PCA), Plainview TX, FDA Form 483 (Inspectional Observations) 2/4/09 – 2/26/09; (7 pages) |
June 01, 2009 |
| Del Rey Tortilleria, Inc., Chicago, IL: FDA Form 483 (Inspectional Observations), 12/04/08 – 01/08/09 (3 pages) |
May 29, 2009 |
| TEVA Animal Health, St. Joseph, MO 483 issued April 21, 2009 (20 pages) |
May 28, 2009 |
| Zimmer Durom Cup Recall Packet, 2007-2008 (162 pages) |
May 27, 2009 |
| Eli Lilly and Company, Indianapolis, IN. Inspection January 29 to February 23, 2001, Warning Letter, FDA 483 and responses from firm: |
January 21, 2009 |
| Schering-Plough, Manati, Puerto Rico: |
January 21, 2009 |
| Boston Scientific, 483 Inspectional Observations, six locations: |
January 13, 2009 |
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