FDA 483 - FARMAKEIO OUTSOURCING LLC - June 10, 2022

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