# FDA 483 - FARMAKEIO OUTSOURCING LLC - June 10, 2022

Source: https://www.keypedia.com/records/483/farmakeio-outsourcing-llc/bdc6e399-0370-48f1-b518-895ca081ea66

> FDA 483 for FARMAKEIO OUTSOURCING LLC on June 10, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FARMAKEIO OUTSOURCING LLC
- Inspection Date: 2022-06-10
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details observations from an inspection of a facility manufacturing hormone replacement pellets.

**Violations and Observations:**

1.  **Release of Drug Product Without Complete Testing:** The Pharmacist/Quality Director released lots of hormone replacement pellets (e.g., Testosterone/Triamcinolone Acetate Pellet 200mg/40mcg, Lot (b)(4); Estradiol Pellet 25mg, Lot (b)(4)) for distribution without laboratory data confirming sterility, potency, and endotoxin limits were met. The firm's SOP QMS-3015, "Finished Product Release Testing," does not address this practice.
2.  **Lack of Stability Data for Expiration Dates:** Testosterone pellets containing (b)(4) are assigned a (b)(4) beyond use date/expiration date without supporting stability data to assure quality throughout the shelf life.
3.  **Unsound Potency Specifications:** The potency specification for Triamcinolone is set at (b)(4) instead of the scientifically recognized (b)(4). This allowed at least (b)(4) lots of Testosterone/Triamcinolone pellets to be released with sub-potent or super-potent Triamcinolone between 6/1/2021 and the inspection date.
4.  **Inadequate Documentation and Approval of Procedures:** Changes to the quantity of Triamcinolone acetonide in accumulation

## Related Documents

- [483 - 2019-10-30](https://www.keypedia.com/records/483/farmakeio-outsourcing-llc/87486782-36e0-49a8-9915-94acd9a04784)
- [WARNING_LETTER - 2019-10-30](https://www.keypedia.com/records/warning_letter/farmakeio-outsourcing-llc/593a8c25-925a-49f8-8d32-a6527aab6853)
- [483 - 2025-08-18](https://www.keypedia.com/records/483/farmakeio-outsourcing-llc/e333d6ab-43c3-40ed-ba62-3ab5769e7acb)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/farmakeio-outsourcing-llc/2e6c1485-c454-4601-ae00-55b1762320e3

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9