Firm Name | Date of Registration as an Outsourcing Facility1 | End Date of Last 2 | Inspection Related to CompoundingWas a Form FDA-483 issued?3 | Other FDA Action, if Any, Based on Last Inspection4,5 | Compounds Sterile Drugs From Bulk Drug Substances6 |
---|---|---|---|---|---|
Advanced Pharma, Inc., Houston, TX
|
1/22/2014 | 3/17/2014 | Yes2 | Open | No |
Alexander Infusion LLC dba Avanti Health Care, New Hyde Park, NY | 4/21/2014 | 7/9/2014 | Yes | Open | Yes |
ALK-Abelló, Inc.,
|
6/3/2014 | 2/25/2014 | Yes | Open | Yes |
Allergy Laboratories, Inc., Oklahoma City,
OK
|
12/30/2013 | 4/26/2013 | Yes3 | Warning Letter - 9/4/20134 | Yes |
Amerilab LLC, Edmond, OK
|
5/23/2014 | Not yet inspected | N/A | N/A | No |
Avella of Deer Valley, Phoenix, AZ | 2/24/2014 | 2/25/2013 | Yes5 | Warning Letter - 1/17/20146 | No |
, | 12/26/2013 | Not yet inspected | N/A | N/A | No |
California Pharmacy and Compounding Center, | 4/30/2014 | Not yet inspected | N/A | N/A | Yes |
Cantrell Drug Company, Litte Rock, | 12/16/2013 | 11/4/2013 | Yes7 | Open | Yes |
Central Admixture Pharmacy Services, Inc., Allentown, PA | 2/28/2014 | 6/11/2014 | Yes8 | Open | Yes |
Central Admixture Pharmacy Services, Inc., San Diego, CA
|
6/4/2014 | 8/8/2014 | Yes | Open | No |
Complete Pharmacy and Medical Solutions, Miami Lakes, FL | 6/6/2014 | Not yet inspected | N/A | N/A | Yes |
Delta Pharma, Inc., Ripley, MS | 8/6/2014 | 10/2/2013 | Yes9 | Open | Yes |
Edge Pharmacy Services LLC, Colchester, VT | 1/21/2014 | Not yet inspected | N/A | N/A | Yes |
Essential Pharmacy Compounding Division of Kohll's Pharmacy, Omaha, NE | 7/17/2014 | Not yet inspected | N/A | N/A | Yes |
Exela Pharma Sciences, LLC., | 6/6/2014 | Not yet inspected | N/A | N/A | Yes |
Greer Laboratories, Inc., Lenoir, NC | 2/24/2014 | 11/15/2013 | Yes10 | Open11 | Yes |
Healix Infusion Therapy, Inc., Sugar Land,
TX
|
2/12/2014 | 5/16/2014 | Yes12 | Open | Yes |
Infusion Options Inc., Brooklyn, NY | 1/24/2014 | 4/23/2014 | Yes13 | Open | No |
Institutional Pharmacy Solutions, LLC, Virginia Beach, VA | 3/4/2014 | Not yet inspected | N/A | N/A | No |
Institutional Pharmacy Solutions, LLC, | 3/6/2014 | 6/20/2014 | No | Open | No |
IV Specialty Ltd, Austin, TX | 2/26/2014 | 7/22/2014 | Yes | Open | No |
JCB Laboratories, North
|
1/21/2014 | 2/27/2013 | Yes14 | Warning Letter - 7/7/201415 | Yes |
Jubilant HollisterStier LLC, Spokane, WA | 6/3/2014 | 4/15/2014 | Yes | Open | Yes |
Kings | , Inc., Brooklyn, NY12/23/2013 | 3/14/2014 | Yes16 | Open | Yes |
KRS Global Biotechnology, Inc., Boca Raton, FL | 12/15/2013 | 3/17/2014 | Yes17 | Open | Yes |
LEESAR INC, Fort Myers, FL | 4/30/2014 | 8/8/2014 | Yes | Open | No |
Leiter's Compounding, (Great Oaks Blvd), San Jose, CA | 1/31/2014 | Not yet inspected | N/A | N/A | Yes |
Lowlite Investments, Inc. dba Olympia Pharmacy, | 3/17/2014 | 3/21/2013 | Yes18 | Warning letter - 2/18/201419 | No |
Medi-Fare Drug & Home Health Center, Inc.,
Blacksburg SC
|
12/17/2013
|
1/18/2013
|
Yes20
|
Yes | |
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | 7/15/2014 | Not yet inspected | N/A | N/A | Yes |
OPS International, Inc. dba Olympia Pharmacy, Orlando, FL | 3/10/2014 | Not yet inspected | N/A | N/A | Yes |
Pharm D Solutions dba PDS Compounding, West Houston, TX | 8/6/2014 | Not yet inspected | N/A | N/A | Yes |
Pharmaceutic Labs, LLC, Albany, NY | 3/10/2014 | Not yet inspected | N/A | N/A | Yes |
Pharmagen Laboratories Inc.,
|
1/21/2014 | 8/23/2013 | Yes22 | Open | Yes |
Pharmakon Pharmaceuticals, Noblesville, IN | 1/23/2014 | 3/13/2014; 4/8/2014 |
Yes
|
Open | No |
Pharmalogic CSP Inc., Bridgeport, WV | 7/1/2014 | Not yet inspected | N/A | N/A | No |
PharMedium Services, LLC, Cleveland,
MS
|
12/11/2013 | 2/22/2013 |
Yes25
|
Warning letter - 7/18/201426 | No |
PharMedium Services, LLC, Edison, NJ
|
12/11/2013 | 2/28/2013 |
Yes27
|
Warning letter - 7/18/201428 | No |
PharMedium Services, LLC, Memphis, TN
|
12/11/2013
|
3/22/2013
|
Yes29
|
No | |
PharMedium Services, LLC, Sugar Land,
TX
|
12/11/2013
|
2/27/2013
|
Yes31
|
Warning letter - 7/18/201432 | No |
Pine Pharmaceuticals, LLC, Tonawanda, NY | 6/17/2014 | Not yet inspected | N/A | N/A | Yes |
Premier Pharmacy Labs Inc., Weeki Wachee, FL | 4/16/2014 | 5/9/2014 | Yes33 | Open | Yes |
Professional Pharmacy & Compounding Services LLC, Miami, FL | 6/13/2014 | Not yet inspected | N/A | N/A | Yes |
RC Compounding Services LLC, Poland, OH | 2/12/2014 | 2/7/2013 | Yes34 | Warning Letter - 7/14/201435 | Yes |
Region Care, Inc., | 12/24/2013 | 3/20/2014 | Yes36 | Open | Yes |
|
12/13/2013
|
4/1/2014
|
Yes37 | Open | Yes |
SSM St. Clare Health Center, Fenton, MO | 2/18/2014 | Not yet inspected | N/A | N/A | No |
Texas Health Infusion, | 8/8/2014 | Not yet inspected | N/A | N/A | Yes |
Triangle Compounding Pharmacy Inc.,
|
1/24/2014 | 3/1/2013 | Yes38 | Warning Letter - 1/14/201439 | Yes |
UCSF Home Therapy Services, San Francisco, CA | 5/29/2014 | 9/20/2004 | No | No | Yes |
Unique Pharmaceuticals, Ltd., | 1/17/2014 |
4/2/2014;
6/20/2014
|
Yes
|
FDA Requested Recall Letter 7/11/1442 (PDF - 754KB) | Yes |
US Compounding, Inc., | 12/20/2013 | 3/27/2014 | Yes43 | Open | Yes |
US Specialty Formulations LLC,
|
1/31/2014 | Not yet inspected | N/A | N/A | Yes |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, August 16, 2014
Look at how the List of Registered FDA Outsourcing Facilities is Growing: Several from Texas Added so far in August
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