FDA 503B Registered Human Drug Compounding Outsourcing Facilities

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 4/27/2026

• Information Concerning Outsourcing Facility Registration
• Outsourcing Facility Product Reporting Information 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.

608-221-7800
Ext 1113 | 1/24/2024 | 11/25/2025 | 6/27/2025 | 483 | N/A | Open | Yes |
| BSO LLC, Lakewood, CO | Michelle Violi
608-221-7800
Ext 1113 | 11/24/2015 | 11/26/2025 | 7/16/2025 | 483 | No | Regulatory Meeting Held 3/3/2026 | Yes |
| Central Admixture Pharmacy Services, Inc., Allentown, PA | Eric Bauer
1-551-204-4178 | 2/28/2014 | 11/21/2025 | 9/5/2025 | Yes | No | Open 7 | Yes |
| Central Admixture Pharmacy Services, Phoenix, AZ | Eric Bauer
1-551-204-4178 | 3/29/2018 | 11/21/2025 | 9/5/2025 | Yes | No | Open 7 | Yes |
| Delta Pharma, Inc., Ripley, MS | Stuart Simpson
662-512-5191 | 8/6/2014 | 12/31/2025 | 11/21/2025 | Yes | No | Open 7 | Yes |
| Denver Solutions, LLC, dba Leiters Health, Englewood, CO | Barbara Knightly
720-697-5140
Ext 4004 | 3/24/2017 | 11/28/2025 | 12/11/2025 | Yes | No | Open 7 | Yes |
| Denver Solutions, LLC, dba Leiters Health, Buena, NJ | Barbara Knightly
720-697-5140
Ext 4004 | 7/1/2022 | 11/26/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Eagle Pharma, Birmingham, AL | Haleigh Cawood
205-682-7999 | 6/16/2015 | 12/16/2025 | 2/27/2025 | Yes | No | Open 7 | Yes |
| Empower Pharma, Houston, TX | Shaun Noorian
877-562-8577 | 7/16/2016 | 11/24/2025 | 11/14/2025 | Yes | No | Open 7 | Yes |
| F.H. Investments, Inc., Birmingham, AL | Christopher S. Musser
1-205-995-0505 | 5/13/2025 | 12/2/2025 | 12/19/2025 | Yes | No | Open | Yes |
| Farmakeio Outsourcing LLC, Southlake, TX | Cody Boatman +1-817-203-8216 | 12/12/2018 | 12/12/2025 | 9/5/2025 | Yes | No | Open 7 | Yes |
| Fagron Compounding Services dba Fagron Sterile Services, Wichita, KS | Deborah McHugh
316-773-0405 | 10/2/2015 | 11/21/2025 | 8/8/2025 | 483 | No | Regulatory Meeting Held 2/27/2026 | Yes |
| Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MA | Deborah McHugh
316-773-0405 | 4/21/2017 | 11/22/2025 | 11/5/2025 | Yes | No | Open 7 | No |
| Galaxy Pharmaceuticals, LLC, Albany, NY | Dalbir Bains
1-646-957-7762 | 1/26/2024 | 11/26/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| GenoGenix LLC, Raton, FL | Horace Smith
1-561-264-7303 | 2/4/2025 | 2/11/2026 | 7/18/2025 | Yes | N/A | Open | Yes |
| GFC Pharma, LLC, Westminster, MD | Ranjeesh Gopinathan
215-264-9995 | 12/16/2024 | 12/30/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ | J. Barton Kalis
856-489-2247 | 9/15/2021 | 12/29/2025 | 6/12/2024 | Yes | No | FMD-145 Issued 12/18/2024 | Yes |
| Hikma Injectables USA Inc., Dayton, NJ | J. Barton Kalis
856-489-2247 | 9/15/2021 | 12/29/2025 | 8/8/2025 | Yes | No | Open 7 | No |
| Hyalo Technologies Limited Liability Company, Somerset, NJ | Shalabh Jain
1-908-399-3600 | 5/1/2025 | 12/3/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Hybrid Pharma, LLC, Deerfield Beach, CA | Ponswamy Rajalingam
954-708-2771 | 1/14/2015 | 12/16/2025 | 11/9/2023 | Yes | No | Open 7 | Yes |
| Imprimis NJOF, LLC, Ledgewood, NJ | Fred Weiss
973-328-8756
Ext=5411 | 11/12/2016 | 11/26/2025 | 4/3/2024 | Yes | No | Regulatory Meeting Held 10/21/2025 | Yes |
| IntegraDose Compounding Services, LLC, Shoreview, MN | Craig Else
1-612-672-6173 | 2/13/2026 | 2/13/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Leesar Inc., Fort Myers, FL | Maria Gautier
1-239-939-8925 | 4/30/2014 | 11/26/2025 | 5/9/2025 | Yes | No | Untitled Letter Issued 11/21/2025 | No |
| Mark Cuban Cost Plus Manufacturing and Compounding, LLC, Dallas, TX | Alexander Oshmyansky
303-907-8003 | 11/2/2022 | 12/14/2024 | 1/28/2026 | Yes | No | FMD-145 Issued 6/5/2025 | Yes |
| McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions, Santa Ana, CA | Jacqueline McKay
714-918-7277
Ext 314 | 1/11/2023 | 12/2/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Medi-Fare Drug, Blacksburg, SC | Artis Terrell, Jr.
1-318-218-3647 | 12/17/2013 | 12/31/2025 | 6/6/2025 | Yes | No | Open 7 | Yes |
| MedisourceRx, Los Alamitos, CA | Venus Firouzehee
1-714-455-1300 | 2/14/2017 | 1/2/2026 | 6/10/2025 | Yes | No | Warning Letter Issued 12/12/2025 | Yes |
| Molecular PharmaGroup, New Providence, NJ | Amanda Lanze
908-588-3440 | 5/8/2018 | 12/30/2025 | 8/11/2025 | Yes | No | Untitled Letter Issued 2/5/2026 | Yes |
| Navinta III Inc., Boca Raton, FL | Mahendra Patel
1-561-997-6595 | 2/6/2026 | 2/6/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | Lou Wood Kennedy
803-569-3110 | 7/15/2014 | 12/15/2025 | 8/22/2025 | 483 | No | Open 7 | Yes |
| Nexgen Formulations, Folcroft, PA | Salman Patha
1-610-455-5125 | 1/15/2026 | 1/15/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Nivagen Pharmaceuticals, LLC, Sacramento, CA | Gopal Patel 1-916-591-0160 | 3/13/2026 | 3/13/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Nubratori, Inc., Torrance, CA | Gulshakar Khwaja
310-218-4153 | 2/24/2017 | 12/3/2025 | 12/11/2025 | Yes | No | Open 7 | Yes |
| Ocyon Bio PR, LLC, Aguadilla, PR | Maria Valex
1-787-612-5681 | 4/23/2026 | 4/23/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Olympia Pharmaceuticals, Orlando, FL | Mark Mikhael
1-407-673-2222 | 3/10/2014 | 11/20/2025 | 8/8/2025 | 483 | No | Open 7 | Yes |
| Orion Specialty Labs, LLC | Kimberly Mattera
1-917-414-2469 | 9/19/2025 | 2/24/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| OSRX, Inc., Missoula, MT | Amy Frost
406-541-6121 | 10/28/2023 | 12/29/2025 | 11/14/2025 | Yes | No | Open 7 | Yes |
| OurPharma LLC, Fayetteville, AR | Shelby Bush
479-313-8200
Ext 8227 | 3/15/2019 | 11/26/2025 | 9/27/2024 | Yes | No | Open 7 | Yes |
| Park Avenue Compounding, St. Louis, MO | Steven Garhartt
603-953-6675 | 12/23/2023 | 11/19/2025 | 9/23/2025 | Yes | No | Open | No |
| PGRrx LLC, Exton, PA | Amit Gupta
1-484-883-7597 | 12/10/2024 | 12/30/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Pine Pharmaceuticals, LLC, Tonawanda, NY | Alfonse Muto
716-248-1025 | 3/9/2018 | 11/19/2025 | 11/14/2025 | Yes | No | Open 7 | Yes |
| PQ Pharmacy LLC, Brooksville, FL | Angela Kassay
352-477-8977 | 10/29/2020 | 12/11/2025 | 4/4/2025 | Yes | No | Warning Letter Issued 10/10/2025 | Yes |
| ProRx LLC, Exton, PA | Mark L'Hommedieu
1-904-616-7355 | 4/27/2022 | 2/20/2026 | 9/19/2025 | Yes | No | Warning Letter Issued 4/7/2026 | Yes |
| Qualgen LLC, Edmond, OK | Shaun Riney
405-463-4141 | 5/23/2015 | 12/17/2025 | 9/4/2025 | Yes | No | Open 7 | Yes |
| Quantum Pharmaceuticals, LLC, Mounds, OK | Albert Sanchez
+479-263-2690; EXT=3062138 | 5/30/2024 | 11/26/2025 | Not yet inspected | Yes | N/A | N/A | Yes |
| Quva Pharma, Inc., Bloomsbury, NJ | David Short
1-908-388-1079 | 9/15/2017 | 12/4/2025 | 4/4/2025 | Yes | No | Open 7 | Yes |
| Quva Pharma, Inc., Sugar Land, TX | Sophia Flores
1-832-500-7450 | 9/10/2015 | 12/2/2025 | 10/28/2024 | Yes | No | Open 7 | Yes |
| RC Outsourcing, LLC, Lowellville, OH | Michael Basista
330-536-8500 | 10/7/2015 | 11/27/2025 | 8/28/2025 | 483 | No | Warning Letter Issued 3/20/2026 | Yes |
| Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX | Jeffrey Crouse
1-817-282-9376 | 7/3/2019 | 11/24/2025 | 7/18/2025 | Yes | No | Regulatory Meeting Held 1/8/2026 | Yes |
| Sankav Pharmaceuticals, LLC, Hackettstown, NJ | Sanjeev K Gupta
1-201-312-8591 | 3/21/2025 | 12/23/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| SCA Pharmaceuticals, Little Rock, AR | Joanna DiStefano
1-877-550-5059 | 12/13/2013 | 12/5/2025 | 10/30/2025 | Yes | No | Open 7 | Yes |
| SCA Pharmaceuticals, Windsor, CT | Joanna DiStefano
877-550-5059 | 8/3/2017 | 12/8/2025 | 3/13/2026 | Yes | No | Open7 | Yes |
| SKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FL | Wales H Stoner III
800-604-5032
Ext 313 | 3/10/2016 | 12/3/2025 | 3/6/2025 | Yes | No | Untitled Letter Issued 9/16/2025 | Yes |
| STAQ Pharma, Inc., Denver, CO | Mark Spiecker
1-303-921-5789 | 2/5/2019 | 12/18/2025 | 2/10/2025 | No | No | FMD-145 Letter Issued 6/6/2025 | Yes |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Mark Spiecker
1-303-921-5789 | 1/26/2023 | 12/18/2025 | 5/16/2025 | Yes | No | Untitled Letter and FMD-145 Letters Issued 12/5/2025 | Yes |
| Staska Pharmaceuticals, Inc., Bennet, NE | Lyndon Leitner
402-782-2207 | 12/3/2020 | 12/12/2025 | 2/20/2026 | Yes | No | Open 7 | Yes |
| Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ | Michael Tursi
888-508-5032 | 1/30/2018 | 11/19/2025 | 5/23/2025 | Yes | No | Open 7 | Yes |
| Tailstorm Health Inc., Chandler, AZ | Mitesh Gandhi
480-274-8617 | 10/23/2019 | 12/6/2025 | 5/23/2025 | Yes | No | Regulatory Meeting Held 11/18/2025 | Yes |
| Tailstorm Health Inc., Phoenix, AZ | Mitesh Gandhi
480-274-8617 | 10/23/2019 | 12/2/2025 | 11/14/2025 | Yes | No | Open 7 | Yes |
| Turbare Manufacturing, Conway, AR | Deketric Smith
501-504-6635 | 6/23/2023 | 12/3/2025 | 1/24/2025 | Yes | N/A | Warning Letter Issued 9/16/2025 | Yes |
| University of Tennessee, Memphis, TN | Harry Kochat
1-901-448-1440 | 5/19/2024 | 3/25/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| US Specialty Formulations LLC, Allentown, PA | Kyle Flanigan
610-849-5023 | 1/31/2014 | 12/3/2025 | 1/14/2026 | Yes | No | Open 7 | Yes |
| Vitae Enim Vitae Scientific, Inc., San Diego, CA | Boris Gites
858-222-0746 | 1/2/2024 | 12/29/2025 | Not yet inspected | N/A | N/A | N/A | No |
| VitalRx Pharmacy, LLC, Houston, TX | Linda Sarpong
1-832-259-1362 | 8/27/2024 | 1/3/2026 | Not yet inspected | N/A | N/A | N/A | Yes |
| Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto
669-297-0857 | 1/31/2014 | 11/25/2025 | 7/3/2025 | Yes | No | Open 7 | Yes |
| Wedgewood Connect Ohio, LLC, Albany, OH | Jamie Grubb
1-859-893-4935 | 10/19/2023 | 12/16/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Wells Pharma of Houston, LLC, Houston, TX | Carissa Imrecke
1-346-888-1010 | 3/9/2020 | 12/3/2025 | 4/13/2026 | Yes | No | Open 7 | Yes |
| Wells Pharmacy, Inc., Dyersburg, TN | Melissa Stefko
800-622-4510 | 6/7/2016 | 11/28/2025 | 4/9/2026 | Yes | No | Open 7 | Yes |
| White Label Pharmacy dba Nova Pharmacy, Katy, TX | Adedoyin Ezekwesili
833-789-3305 | 12/16/2025 | 12/16/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Wesley Pharmaceuticals, Orlando, FL | Mark Mikhael
1-407-440-1555 | 7/25/2025 | 11/22/2025 | 3/16/2026 | No | No | Open 7 | Yes |
| Wilcrest Pharmaceuticals, Inc., Houston, TX | Towobola Louis
1-713-277-4114 | 3/13/2025 | 12/2/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Willowbend Pharma Select, LLC, Houston, TX | Basil Raad
832-628-3260 | 4/11/2024 | 12/12/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Xseer Pharmaceuticals, Inc., Los Angeles, CA | Ali Khosrovni
310-606-0146 | 10/21/2023 | 12/25/2025 | Not yet inspected | N/A | N/A | N/A | Yes |

Notes

1. The "initial date of registration as an outsourcing facility" is the date the facility was first registered (i.e., the date FDA determined that the initial registration information submitted for the facility was complete, and the establishment fee was paid in full).

Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually. A facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee. The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full.

Unless a previously registered outsourcing facility re-registers and pays the annual establishment fee in full during the registration period (between October 1 and December 31 of each calendar year), the facility will be removed from the list of registered outsourcing facilities on January 1 of the next calendar year.
2. Once an outsourcing facility is registered, the facility will be added to the list of facilities FDA intends to inspect according to a risk-based schedule. FDA plans to inspect outsourcing facilities within a reasonable period of time following initial registration, once it is confirmed that the facility has initiated drug production and distribution. However, the exact timing of the inspections can be affected by a number of variables, including the number of outsourcing facility registrants, other inspection priorities, and the operational status of the newly registered outsourcing facility.

Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than one registered outsourcing facility. FDA’s web page Compounding: Inspections, Recalls, and other Actions may contain information about compounding facilities under the same ownership as the listed registered outsourcing facility.

Inspections may take place over several days, weeks or longer. The date of the inspection is the date a Form FDA 483 listing the investigators’ observations was issued. If no FDA Form 483 was issued, the date is the last day of the inspection.
3. A Form FDA 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations.
4. This table does not include State Board of Pharmacy actions, if any. To determine whether a registered outsourcing facility has been the subject of a state enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites.
5. “Closed” means the inspection has been closed without further action. “Open” means FDA has not determined whether further action will be taken. If an action has been taken, it will be listed. Possible FDA actions include warning letter, seizure or injunction.
6. The information in this column 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 not provided this information.
7. This outsourcing facility was the subject of at least one previous inspection relating to compounding that resulted in a Form FDA 483, warning letter or other action. For information about such inspections and resulting actions, visit Compounding: Inspections, Recalls, and other Actions.
8. A remote regulatory assessment (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted remotely, to evaluate compliance with applicable FDA requirements. These assessments assist in protecting human and animal health, inform regulatory decisions and verify certain information submitted to the agency.
9. Based on inspectional findings, the inspection revealed significant issues. As a result, the outsourcing facility may have either initiated a recall on their own following conversation(s) with the FDA investigator or FDA recommended a recall at the conclusion of the inspection or both. Additionally, the outsourcing facility may have conducted multiple recalls or recalled multiple drugs.

• ## Content current as of:

04/27/2026

• Regulated Product(s)

  • Drugs