Farmakeio Outsourcing LLC
FDA 503B outsourcing facility
Southlake, Texas
Key Takeaways
- FDA-registered 503B outsourcing facility since 2018
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: September 5, 2025
- 15 FDA drug recalls on record (2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- December 12, 2018
- Most recent registration
- December 12, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- September 5, 2025
The FDA last inspected Farmakeio Outsourcing LLC on September 5, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
Farmakeio Outsourcing LLC has 15 FDA drug recalls on record in 2025, based on the FDA enforcement database. Breakdown: 15 Class II.
Recall reasons on record include cgmp deviations: potential presence of metal particulate matter.
| Date | Class | Product | Reason |
|---|---|---|---|
| October 2025 | Class II | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimba | CGMP Deviations: Potential presence of metal particulate matter |
| October 2025 | Class II | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX | CGMP Deviations: Potential presence of metal particulate matter |
| October 2025 | Class II | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, | CGMP Deviations: Potential presence of metal particulate matter |
| October 2025 | Class II | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, | CGMP Deviations: Potential presence of metal particulate matter |
| October 2025 | Class II | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S | CGMP Deviations: Potential presence of metal particulate matter |
Showing the 5 most recent of 15 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Farmakeio Outsourcing LLC reports compounding 4 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Estradiol
- Testosterone
- Testosterone; Triamcinolone Acetonide
- Triamcinolone Acetonide; Testosterone
Location
920 S Kimball Ave Ste 100, N/A, Southlake, TX 76092-9019
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Cody Boatman, 817-203-8216. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Farmakeio Outsourcing LLC with the Texas State Board of Pharmacy.
503B facilities in Texas
Texas has 16 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Texas.
Frequently asked questions
Is Farmakeio Outsourcing LLC registered with the FDA?
Yes. Farmakeio Outsourcing LLC is a registered 503B outsourcing facility, first registered with the FDA on December 12, 2018 and most recently registered on December 12, 2025.
Has Farmakeio Outsourcing LLC been inspected by the FDA?
The FDA last inspected Farmakeio Outsourcing LLC on September 5, 2025. A Form FDA 483 was issued.
Has Farmakeio Outsourcing LLC had any FDA drug recalls?
Farmakeio Outsourcing LLC has 15 FDA drug recalls on record (2025) in the FDA enforcement database.
What does Farmakeio Outsourcing LLC compound?
Farmakeio Outsourcing LLC reports compounding 4 active ingredients to the FDA.
Where is Farmakeio Outsourcing LLC located?
Farmakeio Outsourcing LLC is located in Southlake, Texas (920 S Kimball Ave Ste 100).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Farmakeio Outsourcing LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.