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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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ORA Postings

Title Posted Date
2014 Pharmacy Inspections and Related Records April 18, 2014
2013 Pharmacy Inspections and Related Records March 07, 2014
Meridian Medical Technologies and Related Records January 30, 2014
Jacobus Pharmaceutical Company, Inc. January 02, 2014
Biogen Idec. Inc. December 06, 2013
Chobani December 02, 2013
Burzynski Research Institute November 06, 2013
Stanislaw R Burzynski, M.D., Ph.D., Clinical Investigator November 06, 2013
American National Red Cross / Biomedical Services September 26, 2013
Burzynski Research Institute IRB September 22, 2013
Intuitive Surgical, Inc. June 25, 2013
ORA Workplans June 24, 2013
Gilead Sciences, Inc. May 23, 2013
Sunland, Inc. May 21, 2013
St. Jude Medical May 20, 2013
Alexion Pharmaceuticals, Inc. May 03, 2013
Novartis Consumer Health April 29, 2013
Hospira Inc. April 17, 2013
Impax Laboratories, Inc. March 29, 2013
Andrx Pharmaceutical, Inc., Fort Lauderdale, FL, 483 dated 03/06/2006 - 04/18/2006 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 November 15, 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
Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations, 02/26/2008 October 22, 2012
Johnson and Johnson October 19, 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
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
Novartis Consumer Health, Lincoln, NE, Establishment Inspection Report (EIR) 9/9 – 9/11/2008, (13 pages) June 02, 2009
Neways, Inc., Salem, UT, Establishment Inspection Report (EIR), 8/18/2008, (7 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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