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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Application Integrity Policy List

Updated: 10-07-2011

The names of the firms listed below are those that were notified that FDA is deferring substantive scientific review of one or more of the firm's applications and/or is proceeding to withdraw the approved applications.

The asterisk (*) indicates that, to the agency's knowledge, the firm is out of business. This table includes the company's Central File Number and identification number in FDA's electronic Field Accomplishment and Compliance Tracking System (FACTS); or the FACTS Federal Establishment Identification Number (FEI).
 


CENTER FOR DRUG EVALUATION AND RESEARCH

FirmLocationCentral File No./FACTS No.Remarks
Hill Dermaceuticals, Inc.

2650 S. Mellonville Avenue

Sanford, FL  32773-9311

1036365 
Ranbaxy Laboratories, Ltd.
 
Paonta Sahib
Sirmour District
Himachal Pradesh
India
 
3002807978 
Biopharmaceutics Inc.*Bellport, NY2434267/2434267
 
Solopak Pharmaceuticals, Inc.

1. Elk Grove Village, IL

 

1. 51450942 (Tonne Rd.)/1450942 and 51423737 (Chase St.)/3000719798

 

 

2. Franklin Park, IL2. 51419209/1419209
Superpharm Corp.*Bayshore, NY2434256/2434256
 

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

FirmLocationCentral File No./FACTS No.Remarks
Sclavo, S.p.a.*Siena, Italy9610932/1000300459
 

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

FirmLocationCentral File No./FACTS No.Remarks
Bionike, Inc.South San Francisco, CA

No CFN/1000162526

 


 
Bioplasty, Inc.*Minneapolis, MNB2125840/2125840
 
Endotec, Inc.South Orange, NJFEI: 3002400750
 
Micro Detect, Inc.Tustin, CAFEI: 3001697474
 
Sherman Pharmaceutical, Inc.*Abita Springs, LA2310787/2310787
 
SyntronCarlsbad, CA2025760/96782
 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

None


CENTER FOR VETERINARY MEDICINE

None

 

Revision History:

10-07-2011 Added Hill Dermaceuticals, Inc., Sanford, FL, Consent Decree dated 9/27/2011.

07-13-2010 Removed Applied Biotech, Inc., San Diego, CA, Removal Letter dates 07/09/2010.

02-25-2009 Corrected spelling to "Paonta" in CDER section for location of Ranbaxy Labs.
02-24-2009 Added Ranbaxy Laboratories, Ltd., Paona Sahib, India, AIP Notification Letter dated 2/24/2009
Hypertext updated 11.03.2005 tc
09-14-2007 Removed PLUS Orthopedics, San Diego, CA, Removal Letter dated 9/10/2007
10-26-2005 Removed AGA Medical Corporation
09-13-2005 Removed Diagnostic Products Corporation
03-23-2005 Added Applied Biotech, Inc., and removed Biochimica Opos SpA
04-05-2004 Added Plus Orthopedics
03-03-2004 Updated CDRH – AGA Medical Corp, and Added CDRH - Diagnostic Products Corporation
04-10-2003 Removed Gliatech Inc. and Solvay Pharmaceuticals Inc.