76 New Featured FDA 483s | June 14, 2016

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>>

3/27/2015 Aarti Industries Limited Palghar India
3/4/2015 Aesculap Implant Systems LLC Breinigsville PA United States
12/12/2013 Alexian Brothers Hospital Network IRB Arlington Heights IL United States
9/26/2014 Alexion Pharmaceuticals, Inc. Cheshire CT United States
6/30/2015 AMCO International Manufacturing & Design, Inc. Brooklyn NY United States
1/31/2014 Apotex Pharmachem India Pvt Ltd. Bangalore India
2/12/2015 Apotheca Supply, Inc Decatur AL United States
4/11/2014 Arrow Pharm Limited Birzebbugia Malta
3/5/2015 Aurobindo Pharma Limited – Unit 9 Hatnoora, Medak District, Hyderabad India
5/14/2015 Autumn Harp Essex Junction VT United States
10/31/2014 Baeksan Trading Inc. CERRITOS CA United States
1/29/2015 Bell International Laboratories, Inc. Minneapolis MN United States
9/24/2014 Bio-Recovery Inc. Minneapolis MN United States
2/5/2015 BTS S.p.A. Padova Italy
3/16/2015 Burpee Materials Technology, LLC Eatontown NJ United States
3/6/2015 Celltrion Inc. Incheon City Korea (the Republic of)
5/30/2007 Chatta, Gurkamal M.D. Pittsburgh PA United States
3/13/2015 Chongqing Taihao Pharmaceutical Co Ltd Erlang China
7/4/2012 Clinogent (A Division of GVK Biosciences Pvt. Ltd.) Ameerpet (Hyderabad) India
7/8/2015 CNMC Company, Inc. Nashville TN United States
6/5/2014 Complete H2O Minerals West Columbia SC United States
9/11/2014 Conkin Surgical Instruments Ltd. Toronto Canada
7/9/2015 CoreLink LLC Saint Louis MO United States
3/6/2015 Dr. Reddy’s Laboratories Ltd. Visakhapatnam India
2/4/2015 Emcure Pharmaceuticals Limited Hinjwadi, Pune India
4/10/2015 Episciences Inc Boise ID United States
9/27/2012 Exelixis, Inc. South San Francisco CA United States
5/21/2015 Genentech Inc Oceanside CA United States
5/29/2015 Glenmark Pharmaceuticals Limited Solan India
4/20/2006 Goff, John S. Lakewood CO United States
11/25/2014 GP Grenzach Produktions Gmbh Grenzach-Wyhlen Germany
12/11/2014 Health Advances USA, Inc Chula Vista CA United States
2/28/2014 Heartland Products, Inc. Valley City ND United States
4/16/2015 Heritage Pharma Labs, Inc. East Brunswick NJ United States
5/27/2015 Heritage Pharmaceuticals, Inc. Eatontown NJ United States
5/27/2015 Hospira Inc. Lake Forest IL United States
6/17/2015 HSC Development LLC Greenwood Village CO United States
12/4/2014 Jiangsu Kongsung Medical Equip Co., Ltd. Danyang City China
5/8/2015 Kenneth B. Deck, MD Laguna Hills CA United States
9/26/2012 Korea Institute of Toxicology Daejeon Korea, Republic Of (South)
5/8/2008 Kristen N. Ganjoo, M.D. Stanford CA United States
6/4/2015 Lotus Pharmaceutical Company Limited Nantou Taiwan (Province of China)
5/12/2015 Materialise USA LLC Plymouth MI United States
3/20/2014 MedTorque, Inc. Kenosha WI United States
5/13/2014 Micro Labs Limited Vasco Da Gama India
6/5/2015 Miller Technical Services, Inc. Plymouth MI United States
12/4/2014 Mushroom Wisdom, Inc. East Rutherford NJ United States
3/25/2015 Mylan Laboratories Limited, (Nashik FDF) Sinnar, Nashik District India
9/16/2015 Nanotherapeutics, Inc. Alachua FL United States
1/21/2015 Nashat Y Gabrail Md Canton OH United States
3/17/2006 Nashat Y Gabrail Md Canton OH United States
5/28/2015 Neuromuscular Technology, LLC Nashville TN United States
3/5/2014 Nev’s Ink, Inc. Waukesha WI United States
4/24/2014 Nutri Spec Inc Mifflintown PA United States
6/25/2014 NYSW Beverage Brands Halcott Center NY United States
4/17/2015 PAREXEL International GmbH, Early Phase Clinical Unit Berlin Berlin Germany
6/8/2015 PHARBEST Pharmaceuticals, Inc. Farmingdale NY United States
4/24/2014 PreMark Health Science, Inc. Irving TX United States
6/3/2014 Providence Hospital IRB Mobile AL United States
3/9/2015 Quincy Bioscience Holding Company Inc. Madison WI United States
8/7/2014 Robinson Outdoor Products, LLC Cannon Falls MN United States
5/8/2013 Sai Life Sciences Limited Bidar India
10/2/2015 SaveWay Compounding Pharmacy, Inc. Newark DE United States
8/5/2013 Shire Human Genetic Therapies Inc Cambridge MA United States
9/19/2014 Smartpowders Graham NC United States
8/27/2015 Sun Pharmaceutical Industries, Inc. Cranbury NJ United States
12/8/2011 Suzanne K. Gazda, M.D. San Antonio TX United States
12/3/2008 Suzanne K. Gazda, M.D. San Antonio TX United States
10/28/2005 Suzanne K. Gazda, M.D. San Antonio TX United States
2/7/2014 The Muscadine Group, LLC Pine Level NC United States
4/16/2015 Triad Isotopes Macon GA United States
5/8/2014 Western Botanicals, Inc. Spanish Fork UT United States
5/26/2015 Wockhardt Limited Aurangabad India
12/15/2006 Younes, Ziad H, MD Germantown TN United States
5/11/2015 Zimmer Trabecular Metal Technology, Inc. Parsippany NJ United States
6/6/2014 Zipfizz Corporation Mill Creek WA United States

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.


Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
Govzilla Bug

Don’t miss out! Subscribe now

Experience the Power of Govzilla

Get your FREE account to search sites, inspections, & warning letters