FDA 483 - Phamedica Inc. - December 10, 2021

Phamedica Inc. in Plainview, NY, a manufacturer of the PHA S1 Spinal System, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included failures to establish a complete design history file, inadequately document process validation activities, and maintain proper device history records, indicating a lack of control over design and manufacturing processes.