How To Register A 502 Rda

Facilities Registered As Man Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Corrective Act (FD&C Human activity)

This tabular array lists the outsourcing facilities that take submitted registration information that has been determined to be complete past the information lock date for the latest weekly update of the table.

Facility Name	Contact Name and Telephone Number	Initial Date of Registration every bit an Outsourcing Facility¹	Date of Near Recent Registration as an Outsourcing Facilityⁱ	Cease Date of Terminal FDA Inspection Related to Compounding²	Was a Course FDA-483 issued?³	Other Activeness, if Any, Based on Final Inspection⁴ ^, ⁵	Intends to Compounds Sterile Drugs From Bulk Drug Substances⁶
AnazaoHealth Corporation, Las Vegas, NV	Jaclyn Wong 800-995-4363 Ext=3120	9/23/2014	11/ane/2021	9/19/2019	Yes	Alert Letter Issued 8/18/2021	Yes
ANNOVEX PHARMA, INC, Lorton, VA	Kenneth Erickson 540-642-5104	ten/14/2021	ten/14/2021	Not withal inspected	North/A	N/A	Yep
Apollo Care, Columbia, MO	Jarred Dudding 573-441-8900	nine/xiv/2017	12/xiv/2021	nine/8/2021	Yes	Open⁷	Yes
ASP CARES, San Antonio, TX	Raju Sagi 210-417-4567	ii/14/2017	12/xvi/2021	viii/23/2018	Aye	Warning Letter Issued four/5/2021	Yes
Athenex Pharma Solutions, LLC, Clarence, NY	Lori Giles Aleshin 716-812-9475	4/x/2017	ten/18/2021	viii/28/2019	Yeah	FMD-145 Letter Issued 8/10/2021	Yes
Athenex Pharma Solutions, LLC, Dunkirk, NY	Lori Giles Aleshin 716-812-9475	11/2/2021	xi/ii/2021	Not even so inspected	North/A	Due north/A	Yes
Atlas Pharmaceuticals, Phoenix, AZ	Nickolaus Banda 480-208-1855	11/8/2017	1/4/2022	five/21/2021	Yes	FMD-145 Letter Issued v/3/2022	Yes
BayCare Integrated Service Middle, LLC dba BayCare Central Pharmacy, Temple Terrace, FL	Kenneth Jozefczyk 813-901-6339	6/4/2019	12/8/2021	12/10/2019	Aye	FMD-145 Letter Issued 4/4/2022	No
Belcher Pharmaceuticals, LLC, Largo, FL	Shyam Busireddy 727-471-0850	05/18/2021	12/xvi/2021	Not still inspected	N/A	Northward/A	No
Bennett Pharmaceuticals of America LLC, Hudson, WI	James Mulvahill 952-381-9027	iv/19/2022	iv/19/2022	Non yet inspected	N/A	N/A	Yeah
BPI Labs LLC, Largo, FL	Chandra Kasireddy 727-471-0850	iii/4/2019	12/16/2021	iv/30/2021	Aye	FMD-145 Letter Issued nine/10/2021	Yes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT	James Cangelosi 203-775-0862	ane/12/2015	12/30/2021	4/4/2022	Yeah	Open	Yes
BSO LLC, Lakewood, CO	David W. Loma 877-267-3410	11/24/2015	10/29/2021	three/11/2021	Yes	FMD-145 Letter Issued ix/ten/2021	Yeah
Cardinal Admixture Chemist's shop Services, Inc., Allentown, PA	Thomas Kelsey 216-233-0766	2/28/2014	10/22/2021	8/22/2018	Yes	FMD-145 Issued 6/17/2020	Yes
Central Admixture Chemist's Services, Phoenix, AZ	Thomas Kelsey 216-233-0766	3/29/2018	10/22/2021	2/25/2022	Aye	Open⁷	Yes
Central Admixture Chemist's Services, Inc., San Diego, CA	Thomas Kelsey 216-233-0766	6/4/2014	x/22/2021	ix/xi/2018	Yes	FMD-145 Issued 5/27/2020	No
Consummate Pharmacy and Medical Solutions, LLC, Miami Lakes, FL	Charles Richardson 305-397-2035	vi/6/2014	12/22/2021	ane/23/2019	Yes	Regulatory Meeting Held 11/three/2020	Yes
Compound Preferred, LLC, formerly registered as RAM Pharma, Inc., Ammon, ID	Casey Hunter 208-419-0613 Ext=203	7/21/2016	1/12/2022	12/17/2021	Yep	Open⁷	Yes
Delta Pharma, Inc., Ripley, MS	Stuart Simpson 662-512-5191	8/six/2014	1/5/2022	5/20/2022	Yes	Open⁷	Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO	Ron Stephens 408-292-6772	3/24/2017	xi/3/2021	ten/7/2021	Yes	FMD-145 issued 3/29/2022	Yes
Hawkeye Chemist's shop, Inc., Hoover, AL	Haleigh Cawood 205-682-7999	6/16/2015	10/21/2021	8/12/2021	Yep	Open⁷	Yep
Edge Pharma, Winooski, VT	Tyler Wingood 802-992-1178	1/21/2014	11/3/2021	11/30/2021	Yes	Open⁷	Aye
Empower Pharmacy, Houston, TX	Shaun Noorian 877-562-8577	vii/16/2016	ten/19/2021	3/6/2020	Yes	Warning Letter Issued 10/15/2021	Aye
Eurofins Advantar Laboratories, Inc., San Diego, CA	Helena Filippone 619-201-5486	1/10/2022	1/10/2022	Not yet inspected	N/A	N/A	Yes
Exela Pharma Sciences, LLC., Lenoir, NC	Arun Koganti 828-758-5474 Ext=181	6/half-dozen/2014	12/27/2021	7/xviii/2019	Yep	WLCO and FMD-145 Letters Issued 4/30/2021	Yes
F.H. Investments, Inc., dba Asteria Health, Birmingham, AL	William Fixler 855-771-0505	5/eighteen/2017	12/9/2021	7/10/2018	Yes	FMD-145 Letter Issued nine/10/2021	Aye
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS	David Lawn 316-773-0405	ten/ii/2015	10/21/2021	three/24/2022	Aye	Open up⁷	Yeah
Farmakeio Outsourcing LLC, Southlake, TX	Cody Boatman 817-203-8216	12/12/2018	1/5/2022	10/xxx/2019	Yes	Warning Alphabetic character Issued 7/29/2021	Yeah
Fresenius Kabi Compounding, LLC, Canton, MA	Deborah McHugh 781-298-7577	4/21/2017	11/10/2021	12/4/2018	Yeah	FMD-145 Issued four/22/2020	No
Hikma Injectables Us Inc., Dayton, NJ	J. Barton Kalis 856-489-2247	9/fifteen/2021	1/7/2022	Not yet inspected	N/A	N/A	No
Hikma Pharmaceuticals The states Inc., Blood-red Loma, NJ	J. Barton Kalis 856-489-2247	nine/xv/2021	i/7/2022	Not nonetheless inspected	North/A	N/A	Yes
Hybrid Pharma, LLC, Deerfield Beach, FL	Ponswamy Rajalingam 954-708-2771	1/14/2015	11/24/2021	9/3/2021	Yes	Open^vii	Yep
Imprimis NJOF, LLC, Ledgewood, NJ	Heidi Morales 973-804-1623	xi/12/2016	12/29/2021	1/29/2021	Yes	Open⁷	Yes
INTACT PHARMACEUTICALS LLC, New Milford, CT	Debashis Sahoo 860-350-1900	1/12/2018	3/30/2022	ten/12/2018	Yes	Open	Yes
IntegraDose Compounding Services, LLC, Minneapolis, MN	Craig Else 612-672-5216	5/eight/2018	10/9/2021	8/ii/2021	Aye	Think Initiated nine/2021	No
Kashiv BioSciences, LLC, Chicago, IL	Chandramauli Rawal 732-475-0500 ext=110	5/27/2021	12/ii/2021	Non however inspected	Due north/A	N/A	No
KRS Global Biotechnology, Inc., Boca Raton, FL	Charles Richardson 888-502-2050	12/fifteen/2013	12/21/2021	viii/14/2019	Yes	Regulatory Meeting Held 7/thirty/2021	Yes
Leesar Inc., Fort Myers, FL	Maria Gautier 239-939-8925	four/30/2014	12/29/2021	ten/29/2021	Aye	Open^seven	No
Medi-Fare Drug, Blacksburg, SC	Anne-Marie Davis 864-839-6500	12/17/2013	12/7/2021	4/6/2017	No	Untitled Letter Issued 3/xviii/2019	Aye
MedisourceRx, Los Alamitos, CA	Amy Summers 714-455-1300	2/fourteen/2017	eleven/2/2021	10/22/2020	Yep	FMD-145 Issued 6/28/2021	Yes
Molecular PharmaGroup, New Providence, NJ	Amanda Lanze 908-588-3440	5/viii/2018	12/9/2021	Not yet inspected	N/A	Northward/A	Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC	Lou Kennedy 803-569-3110	seven/fifteen/2014	1/20/2022	4/20/2022	Yes	Open up^seven	Yeah
New England Life Care, Inc. dba Advanced Compounding Solutions, Woburn, MA	Roula Samhoun 781-832-5758	3/2/2017	1/4/2022	4/28/2022	Yep	Open⁷	No
Nubratori, Inc., Torrance, CA	Gulshakar Khwaja 310-218-4153	2/24/2017	10/20/2021	12/twenty/2021	No	FMD-145 Letter Issued v/vi/2022	Yes
Olympia Compounding Pharmacy, Orlando, FL	Marco Loleit 407-673-2222	three/x/2014	xi/24/2021	three/2/2022	Aye	Open^seven	Yep
OurPharma LLC, Fayetteville, AR	Morgan Strickland 479-313-8200	3/15/2019	10/xiii/2021	ix/30/2021	Yep	FMD-145 Letter Issued 3/xiv/2022	Aye
Pharmaceutics International, Inc., Cockeysville, MD	Srilatha Jaini 410-584-0001 ext=1167	4/28/2020	one/7/2022	Not however inspected	N/A	Due north/A	Yep
Pharmaceutic Labs, LLC, Albany, NY	Ernesto Samuel 518-210-7164	iii/10/2014	12/22/2021	ix/23/2015	Yep	Warning Letter of the alphabet Issued five/3/2017	Yes
Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY	Alfonse Muto 716-248-1025	iii/nine/2018	x/21/2021	5/xiv/2021	Aye	Open up^vii	Yeah
PQ Chemist's LLC, Brooksville, FL	Angela Kassay 352-477-8977	10/29/2020	11/18/2021	Not yet inspected	North/A	N/A	Yes
Primera Compounding, LLC, Rosenberg, TX	Basil Raad 281-202-6136	five/24/2021	ten/29/2021	Not all the same inspected	N/A	N/A	Yes
Prisma Health Outsourcing Facility, Simpsonville, SC	Gary Jones 864-522-3800	12/nine/2019	ten/23/2021	Non yet inspected	Northward/A	N/A	No
ProRx LLC, Exton, PA	Pardeep Gupta 484-678-8579	four/27/2022	4/27/2022	Not yet inspected	Northward/A	Due north/A	Yes
Providence Wellness & Services-Washington, Tukwila, WA	Jacqueline A. Biery 425-687-4460	3/2/2020	11/22/2021	iv/xiii/2022	Yes	Open⁷	No
Qualgen LLC, Edmond, OK	Shaun Riney 405-551-8216	5/23/2014	12/ii/2021	half dozen/xv/2021	Yeah	Open	Yes
QuVa Pharma, Inc., Bloomsbury, NJ	Robert Brown 908-388-1719	9/15/2017	12/16/2021	5/31/2019	Aye	Regulatory Meeting Held 11/20/2020	Aye
Quva Pharma, Inc., Sugar Land, TX	Robert Nelson 832-495-4216	ix/10/2015	12/xvi/2021	4/23/2019	Yep	Regulatory Meeting Held 11/20/2020	No
QuVa Pharma, Inc., Temple, TX	Travis Leeah 254-933-4429	12/15/2015	12/16/2021	iii/14/2019	Yes	Regulatory Meeting Held 11/xx/2020	Yes
RC Outsourcing, LLC, Lowellville, OH	Raymond R. Carlson 330-536-8500	10/6/2015	12/eight/2021	2/8/2019	Yes	FMD-145 Issued five/22/2020	Yep
Correct Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX	Sara Lange 817-282-9376	seven/3/2019	11/11/2021	eleven/12/2019	Yes	Warning Letter Issued nine/20/2021	Yes
RXQ Compounding LLC, Albany, OH	Tracy Clark 866-280-0031 Ext=8	12/11/2019	1/iii/2022	Non yet inspected	N/A	Northward/A	Yes
SCA Pharmaceuticals, Niggling Rock, AR	Lessley Denton 877-550-5059	12/xiii/2013	12/9/2021	eleven/vii/2019	Yes	WLCO and FMD-145 Letters Issued 8/19/2021	Yes
SCA Pharmaceuticals, Windsor, CT	Lessley Denton 877-550-5059	eight/iii/2017	12/9/2021	xi/nineteen/2019	Yes	FMD-145 Letter Issued 10/22/2021	Yep
Sincerus Florida, LLC, Pompano Beach, FL	Michael Morelli 800-604-5032 Ext=313	iii/10/2016	11/i/2021	ix/17/2018	Aye	FMD-145 Issued 11/16/2020	Yes
SSM Wellness Care Corporation, Fenton, MO	Melissa Mays 636-496-2681	2/18/2014	11/29/2021	nine/28/2021	Yes	Open^vii	No
STAQ Pharma, Inc., Denver, CO	Joe Bagan 303-810-6777	two/5/2019	ane/4/2022	9/29/2021	Yeah	FMD-145 Letter Issued 3/25/2022	Aye
STASKA PHARMACEUTICALS, Bennet, NE	Lyndon Leitner 402-782-2207	12/3/2020	12/25/2021	Not yet inspected	North/A	Northward/A	Yeah
STERRX, LLC, Plattsburgh, NY	Sue Martin 518-324-7879	5/29/2015	xi/29/2021	11/four/2021	Yes	Open⁷	Yes
Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ	Michael Tursi 888-508-5032	ane/30/2018	1/twenty/2022	10/9/2020	Yeah	Open^vii	Yes
Tailstorm Wellness Inc., Chandler, AZ	Andrew Stasiak 520-465-8496	10/23/2019	one/25/2022	7/21/2021	Yep	Open	Yes
The Ritedose Corporation, Columbia, SC	Jody Chastain 803-935-4060	12/xx/2019	eleven/8/2021	iii/22/2022	Yes	Open up	Aye
Academy of Tennessee, Memphis, TN	Harry Kochat 901-448-1440	six/26/2019	12/ii/2021	Non all the same inspected	N/A	North/A	Yes
US Specialty Formulations LLC, Allentown, PA	Kyle Flanigan 610-849-5023	1/31/2014	12/9/2021	4/26/2022	Yes	Open up⁷	Yes
Wedgewood Connect, LLC, formerly registered as Leiter'southward Compounding, San Jose, CA	Paul Yamamoto 408-687-0943	1/31/2014	12/9/2021	12/3/2021	Yes	FMD-145 Letter Issued four/29/2022	Yes
Wells Pharma of Houston, LLC, Houston, TX	Theaquiata A. Mitchell 346-888-1010 Ext=4811	3/9/2020	12/20/2021	vi/17/2021	Yes	FMD-145 issued 1/10/2022	Yep
Wells Pharmacy, Inc., Dyersburg, TN	Melissa Stefko 800-622-4510	6/seven/2016	11/x/2021	ane/28/2021	Yes	Open⁷	Yep

ane.The "initial date of registration as an outsourcing facility" is the date the facility was showtime registered (i.e., the date FDA determined that the initial registration information submitted for the facility was consummate, and for firms commencement registering on or afterward October 1, 2014, the establishment fee was paid in full).

Under section 503B(b) of the FD&C Act, afterwards the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-annals annually. Outset in fiscal year (FY) 2015 (Oct 1, 2014 to September 30, 2015), a facility that elects to register (or re-register) with FDA equally an outsourcing facility must pay an annual establishment fee. The "date of well-nigh recent registration equally an outsourcing facility" reflects the date FDA determined the most recently submitted registration information was consummate and the almanac institution fee for that fiscal year paid in full.

Unless a previously registered outsourcing facility re-registers and pays the annual institution fee in total during the registration flow (between October ane and December 31 of each agenda year), the facility volition be removed from the list of registered outsourcing facilities on January 1 of the next agenda year.

2. Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than than 1 registered outsourcing facility. FDA's web page Compounding: Inspections, Recalls, and Other Actions may comprise information almost compounding facilities under the same ownership every bit the listed registered outsourcing facility.

Inspections may take identify over several days, weeks, or longer. The date of the inspection is the date a Grade FDA-483 listing the investigators' observations was issued. If no FDA Form-483 was issued, the date is the concluding day of the inspection.

iii. A Form FDA-483 is issued when investigators observe any significant objectionable conditions. It does not establish a concluding Agency determination of whether any condition is in violation of the FD&C Human activity or any relevant regulations.

4. This table does not include State Board of Chemist's actions, if whatever. To determine whether a registered outsourcing facility has been the subject of a land enforcement action, check with the Land Lath of Pharmacy for the land in which the facility is located. Some states mail disciplinary or other actions on their web sites.

5. "Closed" means the inspection has been closed without further action. "Open" means that FDA has not fabricated a decision as to whether further activity volition be taken. If an action has been taken, it will be listed. Possible FDA deportment include: alarm letter; seizure; or injunction.

6. The information in this cavalcade was provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. "N/A", indicates the registered outsourcing facility has non provided this data. In the time to come, FDA intends to provide information about whether the outsourcing facility also intends to chemical compound nonsterile drugs from bulk drug substances. That information is not currently bachelor to the Agency.

7. This facility was the subject of at least one previous inspection relating to compounding that resulted in a Form 483, alarm letter, or other action. For information near such inspections and resulting actions, encounter Compounding: Inspections, Recalls, and other Deportment.