# FDA 483 - BIOPTIMAL INTERNATIONAL PTE. LTD. - November 09, 2023

Source: https://www.keypedia.com/records/483/bioptimal-international-pte-ltd/1b629a06-395a-41b1-80f2-f089322797fe

> FDA 483 for BIOPTIMAL INTERNATIONAL PTE. LTD. on November 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BIOPTIMAL INTERNATIONAL PTE. LTD. in Singapore revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish procedures for complaint handling, medical device reporting, corrective and preventive actions, and risk analysis. Additionally, issues were noted with sterilization process validation and device history records.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/bioptimal-international-pte-ltd/8881d933-c435-47dd-8154-61e02c7c708b

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