FDA 483 - Ameridose, LLC - November 09, 2012

During an inspection from October 10 to November 9, 2012, the FDA observed multiple violations at Ameridose, LLC, a sterile drug manufacturer located at 201 and 205 Flanders Rd, Westborough, MA.

**Key Observations and Violations:**

* **Inadequate Product Testing and Release (Repeat Violation):** The firm failed to test the potency of final drug products (admixtures) after dilution from bulk stock solutions. This was linked to approximately 33 complaints of lack of effect/ineffectiveness for products like Ephedrine, Fentanyl, and Oxytocin. Final sterile drug products were also not tested for sterility or bacterial endotoxin after aseptic manual filling operations (e.g., Ropivacaine 0.2%). * **Failure to Investigate Discrepancies:** * Fifty-three instances of microbiological contamination during sterility testing of sterile stock solutions (e.g., Fentanyl, Ropivacaine, Morphine) were not thoroughly investigated. Health hazard evaluations were not initiated, and corrective actions were not implemented. * Three sterility failures (Sodium Bicarbonate, Hydromorphone) were inadequately investigated, lacking root cause determination, corrective actions, or extension to associated lots. Retesting was performed without justification, and microbial identification was insufficient. * Forty-five environmental microbiological excursions in critical areas (personnel fingers,