# FDA 483 - Ceragem Co. Ltd. - May 14, 2018

Source: https://www.globalkeysolutions.net/records/483/ceragem-co-ltd/65e6ac9f-3996-4392-8974-828baaac6b79

> FDA 483 for Ceragem Co. Ltd. on May 14, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ceragem Co. Ltd.
- Inspection Date: 2018-05-14
- Product Type: device
- Office Name: International Compliance Team
- Summary: Ceragem Co. Ltd., a device manufacturer in Cheonan-Si, Korea, received a Form FDA 483 for significant deficiencies in its quality system. The inspection revealed inadequate procedures for complaint handling, a lack of written Medical Device Reporting (MDR) procedures, and insufficient statistical techniques for product acceptance. These observations highlight a need for improved controls to ensure regulatory compliance and product quality.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/ceragem-co-ltd/5a9e9a79-a506-46a8-b6a3-e20d1003506f

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321