Friday, January 10, 2014

FDA Chart and Information on Compounding Registered Outsourcing Facilities

Information quoted from Compounding Registered Outsourcing Facilities

Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 1/3/14
 
 
 
Firm Name
Date of Registration as an Outsourcing Facility1
End Date of Last FDA Inspection Related to Compounding2
Was a Form FDA-483 issued?3
Other FDA Action, if Any, Based on Last Inspection4,5
Compounds Sterile Drugs From Bulk Drug Substances6
Allergy Laboratories, Inc., Oklahoma City, OK
12/30/20134/26/2013YesWarning Letter - 9/4/20131Yes
Banner Health, Chandler, AZ12/26/2013Not yet inspectedN/AN/ANo
Cantrell Drug Company, Litte Rock, AR12/16/201311/4/2013Yes2OpenYes
Kings Park Slope, Inc., Brooklyn, NY12/23/2013Not yet inspectedN/AN/AYes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/2013Not yet inspectedN/AN/AYes
Marlborough Hospital, Marlborough, MA12/26/2013Not yet inspectedNoN/AYes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
12/17/2013
1/18/2013
Yes3
 
Yes
PharMedium Services, LLC, Memphis, TN
12/11/2013
3/22/2013
Yes5
 
Open
No
PharMedium Services, LLC, Edison, NJ
12/11/2013
2/28/2013
Yes6
 
OpenNo
PharMedium Services, LLC, Cleveland, MS
12/11/2013
2/22/2013
Yes7
 
OpenNo
PharMedium Services, LLC, Sugarland, TX
12/11/2013
2/27/2013
Yes8
 
OpenNo
Region Care, Inc., Great Neck, NY12/24/2013Not yet inspectedN/AN/AYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
Not yet inspected
N/AN/AYes
US Compounding, Inc., Conway, AR12/20/2013Not yet inspectedN/AN/AYes

 
 

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