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ORA FOIA Electronic Reading Room

The ORA Electronic Reading Room displays copies of ORA records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information (see 21 CFR Part 20). For other ORA documents, please visit the ORA home page and the FDA Warning Letter page for other FDA documents, please visit the FDA Freedom of Information (FOI) page.

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Title Posted Date
Alaskan Fish Sample Radionuclides Analysis Results Reported by FDA/WEAC (11/22/2013 to 9/9/2014) November 17, 2014
Wholesome Soy Products, Inc. November 14, 2014
2014 Pharmacy Inspections and Related Records November 07, 2014
Spinal Solutions, LLC November 07, 2014
Musculoskeletal Transplant Foundation November 06, 2014
JHP Pharmaceuticals October 30, 2014
Pfizer October 30, 2014
Caraco Pharmaceutical Laboratories October 30, 2014
ORA Workplans October 20, 2014
Sally Jackson Cheeses Oroville, WA 98844 483 issued 12/17/2010 October 08, 2014
Tiny Greens. Urbana, IL 483 issued 1/28/2011 October 08, 2014
Sprouters Northwest Inc., Kent, WA 483 issued 1/21/2011 October 08, 2014
Delta Airlines Inc., Atlanta, GA 483 issued 2/2/2011 October 07, 2014
Zimmer Inc., Warsaw, IN 483 issued 7/22/2011 October 07, 2014
Jazz Pharmaceuticals, Inc., Palo Alto, CA 483 issued 5/6/2011 October 07, 2014
Regeneron Pharmaceuticals, Inc., Rensselaer, NY 483 issued 3/31/2010 October 07, 2014
APP Pharmaceuticals, Grand Island, NY 483 issued 7/8/2011 October 06, 2014
IntelliCell Biosciences, Inc., New York, NY 483 issued 12/12/2011 October 06, 2014
Celltex Therapeutics Corporation, Sugarland, TX, 483 Issued 4/27/2012 October 02, 2014
Hill-Rom, Inc., Batesville, IN, 483 Issued 1/11/2013 October 02, 2014
Kasel Associates Industries, Inc., Denver, CO, 483 Issued 9/28/2012 October 02, 2014
Genentech Inc., South San Francisco, CA 483 issued 9/27/2011 October 02, 2014
Diamond Pet Food Processors of SC LLC, Gaston, SC, 483 Issued 4/20/2012 October 02, 2014
Exemplar Pharmaceuticals LLC, Fall River, MA 483 issued 3/21/2012 October 01, 2014
San Francisco Herb and Natural Food Company, Fremont, CA 483 Issued 7/16/2012 October 01, 2014
Chamberlain Farms Inc., Owensville, IN, 483 Issued 8/31/12 October 01, 2014
2013 Pharmacy Inspections and Related Records October 01, 2014
nSpired Natural Foods September 26, 2014
Diamond Pet Food Processors, Gaston, SC, FDA 483 Inspectional Observations, dated 12/21/2005 - 01/19/2006 July 31, 2014
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 30, 2014
Chi Van Dang, M.D., Ph.D./John Hopkins, Bayview Medical Center, Human Subjects Committee, FDA 483, Insp. Observations (Baltimore) 09/07/2001 July 30, 2014
Bausch & Lomb, Inc., 483 Inspectional Observations, Greenville, SC, dated 03/22/2006 - 05/15/2006, Manufacturer and Repackager/Relabeler establishment types July 30, 2014
Chi Van Dang, M.D., Ph.D./John Hopkins School of Medicine, IRB, FDA 483 Insp. Observations (Baltimore) 09/07/2001 July 29, 2014
FDA issued an notice of default letter, dated June 20, 2008 to Dr. Amile A. Korangy, M.D. and the Korangy Radiology Associates July 29, 2014
University of Illinois @ Urbana - Champaign (Sponsor), Champaign, Illinois, 01/29, 30 & 31/2003, FDA Inspectional Observations July 28, 2014
Guidant Corporation, Saint Paul, MN, September 22, 2005, FDA 483 Inspectional Observations, dated 08/22/2005 - 09/01/2005 July 25, 2014
MedImmune, UK, Ltd., 483 Inspectional Observations, Liverpool, UK, dated 03/26/2007 July 24, 2014
Stryker Corporation July 24, 2014
Able Laboratories, Inc., Cranberry, NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005 July 24, 2014
Andrx Pharmaceutical, Inc., Fort Lauderdale, FL, 483 dated 03/06/2006 - 04/18/2006 July 24, 2014
Cryolife, Connie J. Jones, Kennesaw, GA, 30144, FDA Inspectional Observations, dated 2/14/2003 July 23, 2014
Peanut Corporation of America (PCA), Blakely, GA: Consumer Complaints July 17, 2014
RTI Biologics, Inc. July 15, 2014
Burzynski Research Institute July 15, 2014
Stanislaw R Burzynski, M.D., Ph.D., Clinical Investigator July 15, 2014
Intuitive Surgical, Inc. July 15, 2014
Burzynski Research Institute IRB July 15, 2014
Gilead Sciences, Inc. July 15, 2014
Alexion Pharmaceuticals, Inc. July 15, 2014
Impax Laboratories, Inc. July 15, 2014
St. Jude Medical July 15, 2014
Johnson and Johnson July 15, 2014
Sunland, Inc. July 15, 2014
Jensen Farms July 15, 2014
CooperVision, Inc. July 15, 2014
Ben Venue Laboratories July 15, 2014
Akorn, Inc. July 15, 2014
Sandoz, Inc. (Novartis) July 15, 2014
Professional Disposables International and Nice Pak Products July 15, 2014
Cetero Research July 15, 2014
Scenic View Dairy LLC July 15, 2014
Egg Rule Assignment 483s July 15, 2014
Scientific Protein Laboratories, LLC July 15, 2014
Ameridose July 15, 2014
New England Compounding Center (NECC) July 15, 2014
Pet Jerky Consumer Complaints Received by ORA District Consumer Complaint Coordinators (January 1, 2007 - July 2, 2012) July 15, 2014
Infupharma, LLC July 15, 2014
Novartis Consumer Health July 15, 2014
Integra LifeSciences July 15, 2014
Thermo Pac LLC (Simply Thick) July 15, 2014
Egg Rule Assignment Establishment Inspection Reports July 15, 2014
Invacare Corporation July 15, 2014
Hospira Inc. July 15, 2014
Snokist Growers July 15, 2014
Depuy Orthopaedics July 15, 2014
Terumo Cardiovascular Systems Corporation July 15, 2014
H & P Industries, Inc. (Triad Group) July 15, 2014
Bravo Farms Cheese, LLC July 15, 2014
Abbott Labs, Inc. (Similac) July 15, 2014
Matrixx Initiatives Inc. July 14, 2014
Aunt Mid's Produce Company July 14, 2014
Haifa Smoked Fish, Inc. July 14, 2014
Willamette Shelling, Inc. July 14, 2014
Pepsi Bottling Group, LLC July 14, 2014
American Red Cross 2009 Adverse Determination Letters July 14, 2014
Alkis Togias, M.D./Johns Hopkins Asthma & Allergy Clinic, Baltimore, MD.: FDA 483 Inspectional Observations; (Baltimore) 06/28/2001 July 09, 2014
CryoLife, Inc., Kennesaw, GA, FDA Inspectional Observations, dated 10/9, 10, & 14/2003 July 01, 2014
Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008 June 27, 2014
Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006 June 27, 2014
Jacobus Pharmaceutical Company, Inc. June 26, 2014
Shelhigh, Inc., Union, NJ, May 2, 2007, FDA Requested Recall June 26, 2014
American National Red Cross / Biomedical Services June 20, 2014
Edwards Lifesciences, LLC June 18, 2014
Evergreen Fresh Sprouts June 11, 2014
Morton Grove Pharmaceuticals, Inc. May 30, 2014
Meridian Medical Technologies and Related Records January 30, 2014
Biogen Idec. Inc. December 06, 2013
Chobani December 02, 2013
Alaunus Pharmaceutical LLC, Framingham, MA, 483 Issued 11/16/2012 November 19, 2012
McNeil Healthcare October 05, 2012
Jerky Pet Food Lab Samples Analyzed - 1/1/2007 - 7/2/2012 July 17, 2012
Eli Lilly and Company, Indianapolis, IN. Inspection January 29 to February 23, 2001, Warning Letter, FDA 483 and responses from firm: January 11, 2011
Boston Scientific, 483 Inspectional Observations, six locations: January 11, 2011
Duran and Sons LLC Derry, NM 87933 483 issued 11/22/2010 December 23, 2010
Schering-Plough, Manati, Puerto Rico: December 21, 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
Plainview Milk Products Cooperative December 21, 2010
Bi-County Farm Bureau Coop Association December 21, 2010
Setton International Foods December 21, 2010
Unico Holdings Documents December 21, 2010
Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006 and Warning Letter dated 06/30/2006 December 17, 2010
L. Perrigo Co. December 17, 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
Estrella Family Creamery, LLC, Montesano, WA 483 issued 9/10/2010 October 26, 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
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
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
Unilever Covington, Covington, TN FDA Form 483 12/11/2009 (1 page) December 28, 2009
Genzyme Corporation, Allston, MA, FDA Form 483 11/13/2009 November 25, 2009
Care-Tech Labs Inc., Signed Consent Decree issued 9/8/2009 October 15, 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
Nestle USA, Inc. Danville, VA. Form 483 (Inspectional Observations). 06/18/2009 - 07/09/2009 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
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


 

Page Last Updated: 11/17/2014
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