FDA 483 - Pallimed Solutions, Inc. - March 22, 2013

The FDA Form 483 details numerous deficiencies observed during an inspection of a facility producing sterile injectable drug products.

**Facility and Operations:** The firm compounds various sterile injectable drug products, including Alprostadil, DMSO, BIMIX, Bacteriostatic Water, TRIMIX, Human Chorionic Gonadotropin (HCG), Sermorelin, and Testosterone Cypionate. Operations involve compounding, lyophilization, and aseptic filling.

**Violations and Observations:** * **Inadequate Investigations:** Failure to investigate the source of filamentous material and black floaters in multiple lots of sterile injectable products (e.g., Alprostadil, DMSO, BIMIX, Bacteriostatic Water, TRIMIX) observed on 03/22/2013. A prior deviation report from 12/14/2012 regarding brown floating particles in Bacteriostatic Water was not fully investigated, and the contaminated lot was not documented as rejected. Defects in lyophilized HCG (shape/color variation, lack of size uniformity) were also not investigated. * **Environmental Control Deficiencies:** A rip in a glove box sleeve (03/20/2013) lacked microbial ingress evaluation. Cracks and chipped paint were observed in the compounding room ceiling directly above a horizontal flow hood. Yellow/brownish discoloration was noted on the metal grid of a Laminar Flow Hood. Residue covered clear plastic curtains separating the gowning