FDA 483 - Maitland Labs of Central Florida - February 28, 2020

The FDA Form 483 details multiple deficiencies at an outsourcing facility producing sterile drug products, specifically Nalbuphine HCL, 10mg/1mL.

**Aseptic Processing & Environmental Control:** * Aseptic processing areas are deficient in cleaning and disinfection. Non-sterile disinfectant and wipes are used in the Cleanroom and ISO 5 Laminar Flow Hood, and sterile wipes shed particulates. * The firm failed to conduct a smoke study under dynamic conditions within the ISO-5 Laminar Flow Hood used for Nalbuphine HCL production.

**Quality System & Investigations:** * The firm failed to thoroughly review unexplained discrepancies. Specifically, 93 vials of Nalbuphine HCL, lot #20200108, failed visual inspection for fibers, but no investigation or corrective actions were taken. * Alarms (exhaust rate too fast, door unsealed) on the lyophilizer during processing of Nalbuphine HCL, lot #20200108, were not evaluated for their impact on the batch, despite subsequent maintenance.

**Stability & Testing:** * There is no written stability testing program. The firm failed to follow appropriate stability requirements (temperature/humidity) for Nalbuphine HCL, lot #2019111 R&D, lacking data to support a 12-month expiration date for lot #202001