Friday, October 23, 2015

FDA Registered Outsourcing Facilities as of 10/16/2015

Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 10/16/15
This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table. 
Facility NameInitial Date of Registration as an Outsourcing Facility1Date of Most Recent Registration as an Outsourcing Facility1End Date of Last FDA Inspection Related to Compounding2Was a Form FDA-483 issued?3Other Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc., Houston, TX
1/22/201410/15/20153/17/2014YesOpenNo
Alexander Infusion LLC dba Avanti Health Care, New Hyde Park, NY4/21/20141/7/20157/9/2014YesWarning Letter - 3/27/2015Yes
AnazaoHealth Corporation, Las Vegas, NV9/23/201412/29/20141/30/2015YesOpenYes
Avella Specialty Pharmacy, Phoenix, AZ2/24/20141/20/20157/31/2015YesOpen7No
Banner Health, Chandler, AZ12/26/20131/27/20153/20/2015YesOpenNo
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT1/12/20151/12/20154/9/2015YesOpenYes
California Pharmacy and Compounding Center, Newport Beach, CA4/30/201411/24/2014
8/25/2014;
10/17/2014
Yes
Warning Letter - 6/17/2015Yes
Cantrell Drug Company, Little Rock, AR12/16/201312/30/201411/4/2013YesWarning Letter - 1/21/2015Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/201412/15/20142/11/2015YesOpen7Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/201412/15/20148/8/2014YesOpenNo
Coastal Meds LLC, Biloxi, MS12/23/201412/23/20149/23/2015YesOpenYes
Complete Pharmacy and Medical Systems, Miami Lakes, FL6/6/20141/13/20158/12/2014YesOpenYes
Delta Pharma, Inc., Ripley, MS8/6/20143/10/201510/2/2013YesWarning Letter - 12/9/2014Yes
Downing Labs, LLC, Dallas, TX6/23/20156/23/201510/9/2015YesCeased sterile operations and recalled sterile products 7Yes
Eagle Pharmacy, Inc., Birmingham, AL6/16/20156/16/20158/21/2015YesOpenYes
Edge Pharmacy Services, LLC, Colchester, VT1/21/201410/16/20158/20/2014YesOpenYes
Exela Pharma Sciences, LLC, Lenoir, NC6/6/20141/5/201511/21/2014YesOpenYes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS10/2/201510/2/2015Not yet inspectedN/AN/AYes
Hybrid Pharma, LLC, Deerfield Beach, FL1/14/20151/14/2015Not yet inspectedN/AN/AYes
ILS Genomics, LLC Morrisville, NC8/7/2015 8/7/2015 Not yet inspected N/A N/A No 
INCELL Corp., LLC, San Antonio, TX  5/29/2015 5/29/2015 Not yet inspected N/A N/A Yes 
Infusion Options Inc., Brooklyn, NY1/24/201412/23/20144/23/2014YesOpenNo
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT7/14/20157/14/20158/28/2015YesOpenYes
JCB Laboratories, North Wichita, KS
1/21/201411/25/20142/27/2013YesWarning Letter - 7/7/2014Yes
Jubilant HollisterStier LLC, Spokane, WA6/3/20142/13/201512/02/2014YesOpen7Yes
Kings Park Slope, Inc., Brooklyn, NY12/23/20131/5/20153/14/2014YesWarning Letter - 3/27/2015Yes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/20131/7/20153/17/2014YesWarning Letter - 7/6/2015Yes
LeeSar, Inc., Fort Myers, FL4/30/20141/30/20158/8/2014YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA1/31/20141/26/201510/7/2014YesOpenYes
Medi-Fare Drug, Blacksburg, SC12/17/201312/31/20149/12/2014YesOpen7Yes
Medistat RX, LLC, Foley, AL11/21/201411/21/20149/23/2015YesCeased sterile operations and recalled sterile products7Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/201412/29/2014Not yet inspectedN/AN/AYes
OPS International Inc., Olympia Pharmacy, Orlando, FL3/10/20141/27/201512/4/2014YesOpen7Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL9/21/20159/21/2015Not yet inspectedN/AN/AYes
Pharmaceutic Labs, LLC, Albany, NY3/10/20141/28/20159/23/2015YesOpenYes
Pharmakon Pharmaceuticals, Noblesville, IN1/23/201412/2/20143/13/2014; 4/8/2014
Yes
Warning Letter - 5/21/15No
Pharmalogic CSP, Bridgeport, WV7/1/20141/5/201512/12/2014YesOpenYes
Pharm D Solutions, LLC, Houston, TX8/6/20143/24/20156/5/2015YesOpenYes
PharMedium Services, LLC, Cleveland, MS
12/11/201311/24/20147/16/2015 Open7No
PharMedium Services, LLC, Memphis, TN12/11/201311/24/20147/10/2015
 
Open7
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
11/24/2014
9/24/2015
Yes 
Open7
No
Pine Pharmaceuticals, LLC, Tonawanda, NY6/17/201410/7/201510/9/2015YesNoYes
Premier Pharmacy Labs Inc., Weeki Wachee, FL4/16/201412/18/20145/9/2014YesWarning Letter - 4/27/2015Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK5/23/20145/8/20159/17/2015YesRecall of sterile productsYes
Quva Pharma, Inc., Sugar Land, TX9/10/20159/10/2015Not yet inspectedN/AN/ANo
RC Outsourcing, LLC, Lowellville, OH10/6/201510/6/2015Not yet inspectedN/AN/AYes
Resource Optimization and Innovation, Springfield, MO9/22/20159/22/2015Not yet inspectedN/AN/ANo
RXQ Compounding LLC, Athens, OH1/2/20151/2/20159/21/2015YesOpenYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
12/22/2014
4/1/2014
YesWarning Letter - 6/25/2015Yes
SSM St. Clare Health Center, Fenton, MO2/18/20141/5/20158/14/2014YesOpenNo
STERRX, LLC, Plattsburgh, NY  5/29/2015 5/29/2015 Not yet inspected N/A N/A Yes 
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/201412/15/2014
9/22/2014;
1/16/2015
Yes (9/22/2014and 1/16/2015)Open7Yes
Unique Pharmaceuticals, Ltd., Temple TX1/17/201411/25/2014
1/23/2015
Open7Yes
US Compounding, Inc., Conway, AR12/20/201312/24/20148/21/2015YesCeased sterile operations and recalled sterile products7Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/201411/28/20145/29/2015YesOpenYes

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