# FDA 483 - IDS LTD - April 25, 2019

Source: https://www.keypedia.com/records/483/ids-ltd/a4411995-ffdb-4843-9b90-435f2a005cb8

> FDA 483 for IDS LTD on April 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IDS LTD
- Inspection Date: 2019-04-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of IDS LTD, a medical device manufacturer in Seoul, Korea, revealed a significant issue with their device history records. The firm failed to demonstrate that devices were manufactured in accordance with 21 CFR 820. Specifically, device history records lacked or did not refer to the location of primary identification labels, labeling, and unique device identifiers (UDI) for each production unit.

## Related Documents

- [483 - 2024-08-23](https://www.keypedia.com/records/483/ids-ltd/e3c54898-92e7-4ffe-9151-c807f91d6e8d)

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/ids-ltd/07396322-d04c-4838-bb5e-e0225133c691

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