FDA WARNING_LETTER - Pallimed Solutions, Inc. - March 29, 2013

An FDA inspection of Pallimed Solutions, Inc. from March 20-29, 2013, revealed insanitary conditions in the production of sterile drug products, including those for erectile dysfunction and hormone replacement, rendering them adulterated under section 501(a)(2)(A) of the FDCA.

Key violations included: - **Visible Particulates:** Approximately 56 vials across 9 sterile drug lots contained visible particulates (e.g., white filamentous material, black floaters). - **Facility and Equipment Deficiencies:** Cracks and chipped paint in the compounding room ceiling, discoloration in the laminar flow hood's metal grid, and unknown residue on plastic curtains. - **Inadequate Sterilization Processes:** The firm used a (b)(4) for sterilization, which the manufacturer recommended for research use only, not parenteral use. The firm also failed to perform (b)(4) testing on the (b)(4) after use. - **Lack of Depyrogenation:** Container-closure systems were not depyrogenated. - **Poor Aseptic Practices:** No fingertip sampling or gowning assessments were performed. Technicians were observed with exposed skin and leaning into the aseptic hood. - **Facility Design Flaws:** Equipment like the lyophilizer was in unclassified areas, requiring transfer of partially stoppered vials from ISO 5 to unclassified areas. There was no continuous monitoring of differential pressure