Pt Ciba Vision BatamAugust 26, 2022

FDA 483 - Pt Ciba Vision Batam - August 26, 2022

Record Details

An FDA inspection of Pt. Ciba Vision Batam in Batam Island, Indonesia, revealed significant compliance issues. The firm failed to submit required Medical Device Reports for device malfunctions and did not adequately validate processes. Additionally, procedures for corrective and preventive actions were found to be deficient.

Company: Pt Ciba Vision Batam
Inspection Date: August 26, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

Open in Dashboard

ID · 80942555-fd34-4a62-9439-9b81321a68ed