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

Source: https://www.keypedia.com/records/483/bioptimal-international-pte-ltd/76891a5b-6a76-4e43-88fd-cec8c43b7dcb

> FDA 483 for BIOPTIMAL INTERNATIONAL PTE. LTD. on November 09, 2023. Product: devices. 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: devices
- Office Name: Food and Drug Administration
- Summary: During a November 6-9, 2023 inspection, the FDA issued a Form 483 to BIOPTIMAL INTERNATIONAL PTE. LTD., a medical device manufacturer in Singapore. The inspection revealed significant deficiencies in the company's quality management system, indicating a lack of adherence to U.S. regulatory requirements for medical devices.

Key observations included inadequate procedures for handling customer complaints, specifically failing to evaluate if complaints warranted Medical Device Reports (MDRs) under 21 CFR 803, and not properly investigating all device failures or maintaining complete complaint records. The company also lacked fully developed and implemented written MDR procedures for timely reporting and proper documentation.

Furthermore, BIOPTIMAL's corrective and preventive action (CAPA) system was found deficient, with incomplete corrective actions, a lack of effectiveness verification for implemented changes, and a failure to initiate CAPAs despite identified complaint trends and risk assessment thresholds being exceeded. The risk analysis for devices like the Thermodilution Catheter was inadequate, as actual device failure rates (e.g., balloon rupture, inflation/deflation issues) significantly surpassed anticipated levels without subsequent updates or risk reduction measures.

Additional issues included the absence of established procedures for sterilisation process validation and incomplete device history records, lacking critical information like primary identification labels and Unique Device Identifiers. BIOPTIMAL INTERNATIONAL has pledged to correct all identified observations, which are crucial for ensuring the safety and effectiveness of its medical devices marketed in the United States.

## Related Documents

- [483 - 2023-11-09](https://www.keypedia.com/records/483/bioptimal-international-pte-ltd/1b629a06-395a-41b1-80f2-f089322797fe)

## Related Officers

- [John Gyorfi](https://www.keypedia.com/people/john-gyorfi/f5c11981-ae33-4b1f-bd9b-cbafdd5e6564)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516