USFDA 483s Published in 2014 by USFDA
23/01/2015 20:41
The ORA (Office ofRegulatory Affairs) ElectronicReading Room displays FDA 483's copies. USFDA is making these records publiclyavailable either (1) proactively at USFDA's discretion or (2) because they are"frequently requested" per the Electronic Freedom of Information ActAmendments of 1996. Some records may be redacted to remove non-publicinformation (see 21 CFR Part 20).
The following are FDA 483 copies published in Year 2014 by USFDA. Hope these are useful to understand the GMP trends and observations pattern. You can utilize some observations of these in your Training programs also.
| Title | Posted Date |
|---|---|
| 2014 Pharmacy Inspections and Related Records | January 22, 2015 |
| 2013 Pharmacy Inspections and Related Records | December 02, 2014 |
| 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 |
| 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 |
| 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 |
| Cetero Research | July 15, 2014 |
| Professional Disposables International and Nice Pak Products | 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 |
