# FDA 483 - DreamCon Co. Ltd. - May 08, 2023

Source: https://www.globalkeysolutions.net/records/483/dreamcon-co-ltd/e1fbb072-0f54-4479-8cfd-01d928eb0228

> FDA 483 for DreamCon Co. Ltd. on May 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DreamCon Co. Ltd.
- Inspection Date: 2023-05-08
- Product Type: device
- Office Name: International Compliance Team
- Summary: DreamCon Co. Ltd., a manufacturer of Daily Wear Soft Contact Lenses, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of validation for the water purification process and inadequate procedures for acceptance activities. Additionally, the firm failed to adequately investigate product complaints or evaluate them for MDR reportability.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/dreamcon-co-ltd/603b9fc8-a0ea-4e86-a7f0-d2ba62fb5d8b

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