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

Source: https://www.globalkeysolutions.net/records/483/pt-ciba-vision-batam/80942555-fd34-4a62-9439-9b81321a68ed

> FDA 483 for Pt Ciba Vision Batam on August 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pt Ciba Vision Batam
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/pt-ciba-vision-batam/3495a73f-1c7b-4cea-8217-f3c93b028705

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd