FDA 483 - Turncare, Inc - June 26, 2023

Turncare, Inc. in Pompton Plains, NJ, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and control of nonconforming products. Additionally, issues were noted with equipment calibration, employee training, management review, quality audits, device history records, and document approval, indicating a pervasive lack of quality system control.